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AG-946 for Sickle Cell Anemia
Phase 1
Recruiting
Research Sponsored by Agios Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant is a healthy male or a female of nonchildbearing potential aged 18 to 55 years inclusive at the time of consent;
Participant has a bodyweight ≥50 kilograms (kg) and body mass index ≥18.5 and ≤32 kilograms per square meter (kg/m^2) at screening;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sad: up to day 13; mad: up to day 49; scd: up to day 56
Awards & highlights
Study Summary
This trial is studying the safety and tolerability of AG-946 in healthy volunteers and participants with sickle cell disease, as well as the effect of food on AG-946 in healthy volunteers.
Who is the study for?
This trial is for healthy adults aged 18-55 and those with sickle cell disease (SCD) aged 18-70. Participants must be non-smokers, in good health, understand the study, and agree to use contraception. Those with SCD should have stable medication doses and adequate organ function. Exclusions include recent surgery, certain medical conditions or drug use that could affect results.Check my eligibility
What is being tested?
AG-946 is being tested for safety and effectiveness in both healthy volunteers through single/multiple dose trials and participants with SCD in an open-label part of the study. The trial will explore how AG-946 behaves inside the body (pharmacokinetics) and its impact on the disease (pharmacodynamics).See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include digestive issues, headaches, fatigue or allergic reactions. Side effects can vary based on individual responses to AG-946.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult between 18 and 55 years old and cannot become pregnant.
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I weigh at least 50 kg and my BMI is between 18.5 and 32.
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I am in good health with normal medical exams and tests.
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I agree to either abstain from sex or use contraception for 90 days after my last treatment dose.
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I am between 18 and 55 years old and cannot have children.
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I understand the study and can give my consent.
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I weigh at least 50 kg and my BMI is between 18.5 and 32.
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I agree not to donate sperm during and for 3 months after the study.
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I have been diagnosed with sickle cell anemia.
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I must take at least 0.8 mg of folic acid daily for the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ sad: up to day 13; mad: up to day 49; scd: up to day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sad: up to day 13; mad: up to day 49; scd: up to day 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SAD and MAD: Number of Participants Who Experienced at Least One AE Related to the Study Drug
SAD and MAD: Number of Participants Who Experienced at Least One Adverse Event (AE), by Severity
SAD and MAD: Number of Participants Who Experienced at Least One Serious Adverse Event (SAE)
+7 moreSecondary outcome measures
Area Under the Effect Curve (AUEC) from Time zero to t for 2,3-DPG and ATP
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-t), Time Curve from Time Zero to Infinity (AUC0-∞), and Time Curve from Time Zero to Time tau Over the Dosing Interval (AUC0-τ) for AG-946
Changes in the Concentration of 2,3-diphosphoglycerate (2,3-DPG) and Adenosine Triphosphate (ATP) in Whole Blood
+14 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 3: Sickle Cell Disease (SCD) PhaseExperimental Treatment1 Intervention
Participants will receive a range of selected ascending doses of AG-946, orally, QD or using an alternative dosing regimen for 28 days.
Group II: Part 2: Multiple Ascending Dose (MAD) PhaseExperimental Treatment2 Interventions
Participants will receive a range of doses of AG-946 or placebo, orally, once daily (QD) for 14 days or using an alternative dosing regimen for up to 28 days under fasted conditions.
Group III: Part 1: Single Ascending Dose (SAD) PhaseExperimental Treatment2 Interventions
Participants will receive a range of doses of AG-946 or placebo, orally, once on Day 1. AG-946 will be given under fasted or fed conditions.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Agios Pharmaceuticals, Inc.Lead Sponsor
52 Previous Clinical Trials
4,078 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am in good health with no major medical issues.I agree not to donate sperm during and for 3 months after the study.I weigh at least 50 kg and my BMI is between 18.5 and 32.You don't smoke or use any form of nicotine products for at least 3 months before screening.You have a medical condition that could put you at risk or make it difficult to understand the study results.You agree not to use marijuana or any product containing cannabinoids for 7 days before the study visit.You have used illegal drugs or have had an alcohol addiction within the past year before the screening.You have been drinking more than 21 alcoholic drinks per week within the past year before being screened.I am a candidate for a bone marrow transplant that could potentially cure my SCD, but participating in this study would delay or stop me from receiving it.I can avoid caffeine and similar products for 48 hours before and 7 days after treatment.I have been on a stable dose of my SCD medication for at least 3 months.I haven't smoked or used nicotine products for at least 3 months.I am in good health with normal medical exams and tests.I am willing to avoid caffeine and similar products for 48 hours before and 7 days after treatment.I am willing and able to follow all study requirements.I am a healthy adult between 18 and 55 years old and cannot become pregnant.I have no conditions affecting my stomach, liver, kidneys, or had my gallbladder removed that could affect medication absorption or removal.I must take at least 0.8 mg of folic acid daily for the study.I agree to use birth control or remain abstinent during and after the trial as required.I have not taken AG-946, except as part of a specific study group.I weigh at least 50 kg and my BMI is between 18.5 and 32.I haven't taken prescription drugs within 2 weeks or 5 half-lives before starting.I am currently on treatment to improve oxygen delivery by my red blood cells.I agree to either abstain from sex or use contraception for 90 days after my last treatment dose.I have been diagnosed with sickle cell anemia.I am a man and agree to not have sex or use birth control for 3 months after my last dose.I am between 18 and 70 years old.My organs are functioning well.I am a woman who can have children and have a negative pregnancy test.I have taken more than 2 grams of acetaminophen in a day within the last 2 days.I have had a bone marrow or stem cell transplant.You have participated in a research study or had a medical procedure using new equipment within 3 months before starting this trial.You are allergic to any of the ingredients in AG-946.I had surgery less than 6 months ago.I am between 18 and 55 years old and cannot have children.I understand the study and can give my consent.I am willing and able to follow all study requirements.I haven't donated blood, lost more than 500 mL of blood, or received a blood transfusion in the last 3 months.I have a known G6PD deficiency.I have a confirmed diagnosis of pyruvate kinase deficiency.I've had over 6 pain crises due to sickle cell disease that needed hospital care in the last year.I regularly get or got a blood transfusion in the last 3 months.I have not had major surgery in the last 6 months.I haven't taken strong P-gp inhibitors recently.I have taken drugs to boost blood cell production within the last 28 days.I have difficulty communicating with my doctor.I understand the study and agree to participate.I have a history of significant health issues affecting my heart, kidneys, liver, lungs, stomach, blood, nerves, hormones, mental health, bones, urinary system, immune system, skin, or connective tissues.I am participating in both single and multiple dose studies.I haven't taken any over-the-counter medication except vitamins in the last week.I have had cancer before, but it was either skin cancer, cervical carcinoma in situ, or another type that was treated over 5 years ago with no current signs of disease.You have an allergy to any of the ingredients in the study treatment.You have a history of severe mental illnesses like schizophrenia, bipolar disorder, or major depression.You cannot have taken any experimental drugs within the past 3 months or 5 half-lives of the drug, whichever is longer, before starting AG-946 treatment.I can avoid marijuana products for 7 days before and until my last visit.You cannot drink alcohol from 7 days before the study until it ends.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Multiple Ascending Dose (MAD) Phase
- Group 2: Part 3: Sickle Cell Disease (SCD) Phase
- Group 3: Part 1: Single Ascending Dose (SAD) Phase
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04536792 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings to join this clinical trial?
"That is accurate. According to clinicaltrials.gov, the trial which was initiated on July 10th 2020 has been actively recruiting since then and currently requires 64 patients at 8 distinct sites."
Answered by AI
What is the current scale of participants in this trial?
"Affirmative. According to the information on clinicaltrials.gov, this study is actively looking for participants and was first advertised in July 10th 2020 with its most recent update being released November 30th 2022. 64 patients must be recruited from 8 different locations."
Answered by AI
How many healthcare centers are administering the experiment?
"This medical research is taking place at University of Pittsburgh Medical Center, Boston Medical Centre and Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR in the cities of Pittsburgh, Boston and Dallas respectively, plus 8 other sites across America."
Answered by AI
To whom is this clinical trial open?
"This clinical trial is looking for 64 people within the age range of 18 to 70 with anemia and sickle cell. Additionally, participants must meet specific requirements including: being able to complete all assessments and procedures; having a bodyweight greater than 50 kilograms (kg) and Body Mass Index between 18.5 kg/m^2 - 32 kg/m^2; no clinically significant deviations from normal in their medical history, physical examination, vital signs or ECG results; abstaining or using contraception up to 90 days after last dose of treatment if male participant; non-smoker who has not used nicotine products for at least 3 months"
Answered by AI
Has AG-946 been given clearance by the FDA?
"As Phase 1 trials are typically conducted to assess safety, our team at Power judged AG-946's safety as a 1 due to the limited data available related to its efficacy."
Answered by AI
Is the age of 65 an eligibility criterion for this experiment?
"This clinical trial has a minimum age requirement of 18 years and an upper bound of 70 for participant eligibility."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
California
Texas
What site did they apply to?
University of California San Diego
PPD Development, LP
University of Texas Health Science Center of Houston
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To help others like me. I try to give back by doing medical studies to help people survive.
PatientReceived 2+ prior treatments
I am very proud to be a healthy subject with no prior surgeries, not of child bearing age, on no medications, no health conditions or known allergies. I want to help people.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of California San Diego: < 48 hours
Average response time
- < 2 Days
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