61 Participants Needed

PF-06414300 for Healthy Subjects

PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to learn about how different amounts of study medicine called PF-06414300 acts and is changed and eliminated from the body of healthy adult participants. The amount of PF-06414300 in blood after the medicine is taken by mouth will also be measured.The study is seeking for participants who:* Are male or female of 18 to 65 years of age.* Are in good health condition.* Have body mass index of 16 to 32 kilograms per squared meters; and a total body weight of more than 50 kilograms (110 pounds).All participants in this study will receive either PF-06414300 or placebo (dummy pill) by chance. The study will have 2 parts; in the first part of the study (Part A), each participant will receive a total of 4 doses of PF-06414300 or placebo with at least 10 to 14 days between each dose. After each dose, participants will stay in study clinic for 4 to 5 days.In the second part of the study (Part B), each participant will receive a total of 10 doses of PF-06414300 or placebo and participants will stay in study clinic for 14 days.An optional Japanese cohort may be done later. The planned duration of participation from screening to follow up in Part A and B of this study is up to 12 to 14 weeks and 10 to 12 weeks, respectively.Participants will also have their blood collected by the study doctors several times.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking other medications might not be allowed. Please check with the study team for specific guidance.

What data supports the idea that PF-06414300 for Healthy Subjects is an effective drug?

The available research does not provide any specific data or studies about the effectiveness of PF-06414300 for Healthy Subjects. The articles listed focus on other topics, such as patient outcomes after femoral neck fracture, formulary changes, medication access in low-income populations, lipid testing in elderly patients, and heart failure management. Therefore, there is no direct evidence from these sources to support the effectiveness of PF-06414300 for Healthy Subjects.12345

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 with a BMI of 16-32 and weight over 50 kg. It's not suitable for those outside this age range, with health issues, or who don't meet the bodyweight criteria.

Inclusion Criteria

Body mass Index (BMI) of 16-32 kg/m2; and a total body weight >50 kg (110 lb)
I am generally healthy based on recent medical exams.
I am of full Japanese descent with all grandparents born in Japan and weigh over 45 kg.

Exclusion Criteria

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
I have had abnormal bowel movements in the last week.
Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive 4 doses of PF-06414300 or placebo with 10 to 14 days between each dose, staying in the clinic for 4 to 5 days after each dose

12-14 weeks
4 in-clinic stays

Treatment Part B

Participants receive 10 doses of PF-06414300 or placebo, staying in the clinic for 14 days

10-12 weeks
1 in-clinic stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PF-06414300
Trial Overview The study tests how different doses of PF-06414300 are processed by the body when taken orally compared to a placebo. Participants will receive multiple doses across two parts, staying in-clinic post-dose for observation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06414300Experimental Treatment1 Intervention
Participants will receive single or multiple ascending oral doses of PF-06414300
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a study of 182 patients aged 20-69 with femoral neck fractures treated with internal fixation, 73% of those with displaced fractures and 85% with non-displaced fractures reported good or excellent functional outcomes at 24 months.
Despite a significant percentage achieving good functional outcomes, patients did not fully regain their pre-fracture health-related quality of life, indicating that while surgical intervention is effective, it may not restore overall quality of life.
Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients.Campenfeldt, P., Hedström, M., Ekström, W., et al.[2018]
A pilot program involving 6,518 patients showed that notifying patients about formulary changes through targeted letters significantly increased adherence to alternative medications, with a switch rate of 19.2% in the intervention group compared to 12.0% in the control group.
Patients who received the notification letters were 1.33 times more likely to switch to a formulary alternative, demonstrating that personalized communication can effectively enhance patient engagement in their medication choices without limiting access to necessary treatments.
Effect of patient notification of formulary change on formulary adherence.Delate, T., Henderson, R.[2023]
The expansion of a medication formulary effectively increased access to specialist-prescribed medications for low-income populations by utilizing the 340B Drug Pricing Program and patient assistance programs.
Collaboration with community physicians and organizations was crucial for the successful implementation of this formulary expansion, highlighting the importance of community involvement in healthcare access initiatives.
Formulary expansion to provide access to medications prescribed by a specialist in a low-income population.Robbins, C., Stillwell, T., Wilson, S., et al.[2012]

Citations

Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. [2018]
Effect of patient notification of formulary change on formulary adherence. [2023]
Formulary expansion to provide access to medications prescribed by a specialist in a low-income population. [2012]
The effect of primary care management on lipids testing and LDL-C control of elderly patients with comorbidities. [2011]
A heart failure initiative to reduce the length of stay and readmission rates. [2014]
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