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31 Pharmacokinetics And Pharmacodynamics Trials Near You
Power is an online platform that helps thousands of Pharmacokinetics And Pharmacodynamics patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerAZD6244 for Neurofibromatosis
Cincinnati, Ohio
Background:
- Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat them is with surgery. Some of these tumors cannot be completely removed. The tumors may be too large, too numerous, or in a bad location for surgery. An experimental drug called AZD6244 hydrogen sulfate may be able to prevent the tumors from growing, slow down their growth, or shrink them. This drug has been tested in adults with cancer and in children with some types of brain cancer. This study will test how well this drug works with these types of tumors.
Objectives:
- To study the safety and effectiveness of AZD6244 hydrogen sulfate in children and young adults with plexiform neurofibromas that cannot be completely removed by surgery.
Eligibility:
- Children and young adults between 12 and 18 years of age who have plexiform neurofibromas that cannot be completely removed by surgery.
Design:
* Patients will be screened with a physical exam, medical history, blood tests, and imaging studies.
* They will take the study drug twice a day with 8 ounces of water, every day for 28-day cycles of treatment. During study visits, participants will have blood and urine tests and physical exams. They will also have imaging studies to examine the tumor sizes and locations. They will answer questions about their health. They may have other tests as needed.
* Participants will continue to receive the study drug as long as they have no severe side effects and the disease is not getting worse.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:2 - 18
Key Eligibility Criteria
Disqualifiers:Pregnancy, Severe Disease, HIV, Others
Must Not Be Taking:Antiretrovirals, Vitamin E
99 Participants Needed
Belimumab for Lupus
Cincinnati, Ohio
This trial is testing a medication called belimumab, given as an injection under the skin, in children with lupus. The goal is to see if it is safe and effective by calming down their overactive immune systems. Belimumab is approved for the treatment of lupus in adults with moderate disease activity.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:5 - 17
Key Eligibility Criteria
Disqualifiers:Severe Nephritis, Organ Transplant, Malignancy, Others
Must Be Taking:Corticosteroids, Immunosuppressives, Anti-malarials, NSAIDs
25 Participants Needed
BMS-986435 for Heart Failure
Cincinnati, Ohio
This trial is testing a new drug called BMS-986435/MYK-224 in people with a specific type of heart failure (HFpEF). The goal is to see if the drug is safe and if it can help improve heart function and reduce symptoms.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:40 - 85
Key Eligibility Criteria
Disqualifiers:Obstructive Cardiomyopathy, Cardiac Amyloidosis, Others
208 Participants Needed
The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
65 Participants Needed
AB521 for Renal Cell Carcinoma
Cleveland, Ohio
This trial is testing a new drug called AB521 to see if it is safe for people with advanced cancers, including a type of kidney cancer called clear cell renal cell carcinoma. In some parts of the study, AB521 will be used alone, and in others, it will be combined with another drug called cabozantinib, which stops cancer cells from growing.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Cardiac, Respiratory, Psychiatric, Others
Must Not Be Taking:HIF-2α Inhibitors, Cabozantinib
302 Participants Needed
Vancomycin for Obesity
Ann Arbor, Michigan
The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are:
Does dosing vancomycin based on kidney function provide better drug exposure than dosing based on weight? What medical or safety issues arise when vancomycin is dosed according to weight versus kidney function? Participants will be randomized into two groups. One group will receive vancomycin doses based on their weight, while the other will receive doses based on their kidney function.
Participants will:
Receive a single dose of vancomycin based on either their weight or kidney function after pretreatment with antihistamines Provide blood and urine samples at specific times for pharmacokinetic analysis Undergo body composition measurements using DEXA scans and other methods Visit the clinic for physical exams, medical history, and laboratory tests
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Pregnancy, Allergies, Cardiovascular, Renal, Others
Must Not Be Taking:GLP1 Agonists, Ototoxic Drugs
24 Participants Needed
PF-06821497 for Small Cell Lung Cancer
Louisville, Kentucky
This trial is testing a new drug called PF-06821497 to see if it can help adults with certain hard-to-treat cancers. The drug is taken by mouth and is being studied alone or with other treatments to check its safety and effectiveness in stopping cancer growth.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Hypertension, Hypersensitivity, Gastrointestinal Disease, Others
Must Be Taking:Abiraterone, Enzalutamide
343 Participants Needed
GSK4771261 for Polycystic Kidney Disease
London, Ontario
This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given. Part A is testing the new study treatment on healthy people. This is to see if it's safe, what it does to the body, and how the body's defense system responds to it. Part B is similar, but the study treatment will be given to people who have a kidney disease called autosomal dominant polycystic kidney disease (ADPKD).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:25 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Liver Disease, Cancer, Others
Must Not Be Taking:Vitamins, Herbal Supplements
84 Participants Needed
Deuterated Oxytocin for Postpartum Hemorrhage
Chicago, Illinois
Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus.
After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship.
The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Allergy To Oxytocin, Others
100 Participants Needed
Mevrometostat + Enzalutamide for Prostate Cancer
Westmont, Illinois
This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Brain Metastasis, Others
Must Be Taking:Enzalutamide
900 Participants Needed
GSK6097608 + Dostarlimab for Advanced Cancers
Toronto, Ontario
This trial tests new drugs alone or in combination to treat people with advanced solid tumors. The drugs either attack cancer cells directly or help the immune system fight cancer. The study includes Japanese and Chinese participants.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Active Infection, Autoimmune Disease, CNS Metastases, Others
Must Not Be Taking:Immunosuppressants, Chemotherapy
107 Participants Needed
FTX-6058 for Sickle Cell Disease
Fairfax, Virginia
This is a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of Pociredir in participants with sickle cell disease.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Severe Renal Disease, Active Malignancy, Others
Must Not Be Taking:Hydroxyurea, Voxelotor, Crizanlizumab
70 Participants Needed
Aza-TdC for Solid Tumors
Bethesda, Maryland
Background:
Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the instruction book for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were turned off. Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC.
Objective:
To test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans.
Eligibility:
People ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists
Design:
Participants will be screened with:
Medical history
Blood and urine tests
Scans to measure their tumors
Test to measure the electrical activity of the heart
Participants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long.
Week 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment.
For cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks.
The cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better.
Sponsoring Institute: National Cancer Institute
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Pregnancy, HIV, Hepatitis B, Others
Must Not Be Taking:Anti-seizure Medications
65 Participants Needed
Computerized Dosing Tool for Bacterial Infections in Children
Baltimore, Maryland
This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv. Dosing will be individualized based on AUC24/MIC. The results will be compared to matched historical controls.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:< 18
Key Eligibility Criteria
Disqualifiers:Not Listed
75 Participants Needed
Etanercept Dosing for Arthritis
Durham, North Carolina
The purpose of this study is to learn more about how adult and children's bodies use etanercept and how bodyweight influences how well etanercept works. This study will help us understand the proper dose of etanercept in obese children and adults.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:2 - 65
Key Eligibility Criteria
Disqualifiers:Malignancy, Heart Failure, Severe Infections, Others
Must Be Taking:Etanercept
30 Participants Needed
Digoxin for Single Ventricle Heart
Durham, North Carolina
The primary participant will be an infant with single ventricle heart disease.
This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function.
The investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care ("opportunistic"). The investigators will also collect information from medical records.
Being part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:30 - 6
Key Eligibility Criteria
Disqualifiers:Prematurity, High Creatinine, Heart Block, Others
Must Be Taking:Digoxin
20 Participants Needed
Aspirin for High-Risk Pregnancies
Philadelphia, Pennsylvania
Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:16 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Thrombocytopenia, Bleeding Disorders, Others
Must Be Taking:Aspirin
400 Participants Needed
ANAVEX3-71 for Schizophrenia
Marlton, New Jersey
A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Pregnancy, Suicidal Risk, Others
Must Be Taking:Atypical Antipsychotics
71 Participants Needed
Methylphenidate for ADHD
New York, New York
This trial is investigating how genetic differences in an enzyme called CES1 affect the way ADHD patients respond to the medication methylphenidate. The goal is to understand why some patients do not respond well or experience severe side effects. Methylphenidate (MPH) is a well-established treatment for ADHD, but not all patients respond to it, and some experience adverse reactions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Non-ADHD, Smokers, Pregnant, Others
Must Be Taking:Methylphenidate
500 Participants Needed
THC for Pain Relief in Older Adults
West Haven, Connecticut
The overarching goal of this double-blind, placebo-controlled, crossover study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) effects of the main analgesic and psychoactive constituent of cannabis, delta-9 tetrahydrocannabinol (THC), among older adults - the fastest growing population of cannabis consumers, and the most likely age cohort to use cannabinoids to relieve pain. The research will proceed with a sub-study, randomizing 20 men and women aged 65 years or older, to two doses focusing on oral THC administration and a sub-study randomizing 20 men and women aged 65 years or older, to two doses focusing on vaporized THC administration.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:65+
Key Eligibility Criteria
Disqualifiers:Psychiatric Disorders, Respiratory Problems, Neurological Conditions, Others
Must Not Be Taking:Pain Drugs, CYP2C9 Inducers
20 Participants Needed
Why Other Patients Applied
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
ABO-101 for Primary Hyperoxaluria
Rochester, Minnesota
The goal of the redePHine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in participants with primary hyperoxaluria type 1 (PH1). The trial will consist of 2 Study Periods. During the first Study Period, there will be 2 parts. In Part A, adult participants will be treated with a single ascending dose to identify a recommended dose. In Part B, pediatric participants will be treated with the recommended dose. Following the first Study Period, participants will start Study Period 2, a long-term monitoring program to comply with local and national requirements.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:6 - 64
Key Eligibility Criteria
Disqualifiers:PH2, PH3, Transplant, Dialysis, Others
Must Not Be Taking:RNAi, SiRNA Therapies
23 Participants Needed
BIO 300 Oral Suspension for Healthy Volunteers
Saint Paul, Minnesota
This is a two-part study of BIO 300 Oral Suspension in healthy male and female volunteers. The first part is a multiple ascending dose (MAD) study to test the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the drug when given as daily doses over 14 days. The study will enroll three cohorts each receiving a different daily dose: 2000 mg, 3000 mg, or 4000 mg. A fourth group may be added depending on results on the first three cohorts. Each cohort will include 10 participants (5 men, 5 women), with at least 8 completing all study steps. Participants will follow a special diet low in soy-based foods and will fast before certain doses. Blood samples and health checks will be done throughout the study to assess safety, drug is absorption and distribution in the body (PK), and its effects (PD). Safety will be reviewed after each group finishes to decide if the next dose level is safe to proceed.
The second part of the study is a food effect study to examine how food effects the PK of a single dose of BIO 300 Oral Suspension. This study will enroll 16 participants (8 men, 8 women) and will be split into two groups: one group will take the drug after fasting for 10 hours and the other will take the drug after eating a high-fat meal. After a 7-day break, participants will switch conditions (the previously fasted group will take the drug with food, and the previously fed group will take the drug after fasting). Blood samples and health checks will measure how food influences drug absorption (PK) and safety. Both the MAD study and food effect study aim to ensure the drug is safe and provide data on how it behaves in the body under different conditions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Arrhythmia, QTc Prolongation, Hepatitis, Others
Must Not Be Taking:Prescription Medications
56 Participants Needed
Empagliflozin for Kidney Failure
Jackson, Mississippi
The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin.
Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Low Blood Pressure, Cancer, Pregnancy, Others
Must Not Be Taking:SGLT2 Inhibitors
24 Participants Needed
NX-5948 for Healthy Subjects
Lincoln, Nebraska
This is a Phase 1, 2-part double-blinded (with respect to NX-5948/placebo), placebo-controlled study. Part 1 is a randomized, 3 period cross-over food-effect (FE) and drug-drug interaction (DDI) study. Part 2 is a single-period PK evaluation study.
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 55
Sex:Male
Key Eligibility Criteria
Disqualifiers:Not Listed
32 Participants Needed
ASP5502 for Sjögren's Syndrome
Daytona Beach, Florida
Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth. However, other symptoms may occur such as fatigue, joint pain, and skin problems. These symptoms can be severe. Symptoms can be treated but there is an unmet need to treat the actual condition.
In this study, ASP5502 is being given to humans for the first time. The people taking part are healthy adults or adults with pSS. The main aims of the study are to check the safety of ASP5502 and how people tolerate ASP5502.
This study will be in 3 parts. In Part 1, healthy men and women will take tablets of ASP5502 or a placebo just once. In this study, the placebo looks like the ASP5502 tablet but doesn't have any medicine in it. Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another. One small group will take tablets of ASP5502 or placebo with and without food. This is to find out if food affects how the body processes ASP5502.
After their dose, people will stay in the medical center for a few nights. This is to have blood tests, electrocardiograms (ECGs) to check heart health, and other safety checks, and to report any medical problems. One of these checks is to have their heart continuously tracked during the first night. This is called telemetry. People who take tablets of ASP5502 or placebo with and without food will stay in the medical center for a few extra nights.
In Part 2, healthy men and women will take tablets of ASP5502 or a placebo. They will do this once a day for 2 weeks (14 days). Different small groups of people will take a lower to a higher dose of ASP5502 or a placebo. This will happen one group after another.
After taking ASP5502 or the placebo, people will stay in the medical center for a few nights. This is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems. Telemetry will also be done continuously during the first night.
In Part 3, men and women with pSS will take tablets of ASP5502. They will do this once a day for 4 weeks (28 days). Different small groups of people will take a lower to a higher dose of ASP5502. This will either happen for one group after another, or just for 1 group. The number of groups and the doses taken will be worked out from the results from Part 1 and Part 2 of this study. People will stay in the medical center for a couple of nights. This will happen for their first dose, then again after about 2 weeks and 4 weeks of treatment. As in Parts 1 and 2, this is to have blood tests, ECGs to check heart health, and other safety checks, and to report any medical problems.
In all parts of the study, people will return to the medical center about 1 week after their final blood sample is taken, for health check. People in parts 2 and 3 will also receive a telephone call safety check about 4 weeks after their last dose of ASP5502.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Secondary Sjögren's, Severe Complications, Others
Must Not Be Taking:Immunosuppressants, B-cell Depleting, JAK Inhibitors, Others
132 Participants Needed
First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Hepatic, Respiratory, Others
64 Participants Needed
AVR-48 for Safety Evaluation
Austin, Texas
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Alcoholism, Drug Abuse, HIV, Others
Must Not Be Taking:Prescription Drugs
48 Participants Needed
BMS-986465 Safety Study in Healthy Subjects
Austin, Texas
The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Not Listed
132 Participants Needed
Obeticholic Acid for Biliary Atresia
Calgary, Alberta
This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy). The double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:1 - 18
Key Eligibility Criteria
Disqualifiers:Liver Transplant, BASM, Others
Must Not Be Taking:Anticoagulants
144 Participants Needed
Kratom-Oxycodone Interaction Study for Herbal Interaction
Spokane, Washington
This trial is studying how kratom tea affects the body's processing and response to the pain medication oxycodone. Healthy adults will take kratom tea and oxycodone in different combinations. Researchers aim to see if kratom changes how oxycodone is broken down and its effects on the body. Kratom is a herb with a long history of traditional use in Southeast Asia, known for its stimulant properties at low doses and effects similar to opioids at higher doses.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:21 - 45
Key Eligibility Criteria
Disqualifiers:Chronic Illness, Substance Abuse, Others
Must Not Be Taking:Opioids, Amphetamines, Benzodiazepines, Others
16 Participants Needed
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Frequently Asked Questions
How much do Pharmacokinetics And Pharmacodynamics clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Pharmacokinetics And Pharmacodynamics clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Pharmacokinetics And Pharmacodynamics trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Pharmacokinetics And Pharmacodynamics is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Pharmacokinetics And Pharmacodynamics medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Pharmacokinetics And Pharmacodynamics clinical trials?
Most recently, we added Etanercept Dosing for Arthritis, Aspirin for High-Risk Pregnancies and ABO-101 for Primary Hyperoxaluria to the Power online platform.
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