PF-06414300 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, PF-06414300, to observe its behavior in the body when taken orally. The study aims to understand how the medicine is absorbed, metabolized, and eliminated by healthy adults. Participants will be randomly assigned to receive either the actual medicine or a placebo. Eligible participants should be in good health and weigh over 110 pounds. The trial requires staying at the clinic for several days after taking the medicine for blood tests and monitoring. As a Phase 1 trial, participants will be among the first to receive this new treatment, contributing to understanding its effects in people.
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.
Is there any evidence suggesting that PF-06414300 is likely to be safe for humans?
Research shows that PF-06414300 is being tested to understand its effects in the body. As this is an early-stage trial, limited safety information in humans is available. However, early trials primarily focus on assessing the safety of a new treatment. Researchers closely monitor participants for any side effects and how they tolerate the treatment.
Since this is a Phase 1 trial, PF-06414300 has not been extensively tested in humans. Participants receive close monitoring for any adverse effects. Although data is limited, the trial prioritizes safety, and every measure is taken to ensure participants' well-being.12345Why do researchers think this study treatment might be promising?
PF-06414300 is unique because it offers a potentially new way to approach treatment by delivering single or multiple ascending oral doses, which might provide more controlled and adjustable dosing compared to standard treatments. Researchers are interested in its novel mechanism that could target conditions differently from existing therapies, possibly leading to improved outcomes. Additionally, PF-06414300's oral administration can offer greater convenience and adherence compared to options requiring injections or more invasive methods.
What evidence suggests that PF-06414300 could be effective?
The trial is studying PF-06414300 to understand its absorption, processing, and elimination in the body. Participants will receive either PF-06414300 or a placebo. No data currently exists on the effectiveness of PF-06414300 for any condition. This study aims to gather basic information, an important first step before exploring potential benefits in future research.12346
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Treatment Part B
Participants receive 10 doses of PF-06414300 or placebo, staying in the clinic for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PF-06414300
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University