PF-07328948 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to learn how a certain amount of \[14C\] PF-07320948 is taken up into the bloodstream and removed from the body.
This study is seeking participants who are:
* Male between 18 to 64 years of age
* Deemed to be healthy
This is a 2 Part, 4 Period study where Part 1 has Periods 1 and 2 and Part 2, which is optional, has Periods 3 and 4.
Part 1
* Period 1: The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body.
* Period 2: The goal is to compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood.
Part 2 (Optional)
* Period 3 (optional): If needed, the purpose is to see how PF-07328948 acts after taking it daily until the body reaches a steady level.
* In Period 4 (optional), the goal is to check again how much PF-07328948 is absorbed and leaves the body after daily dosing.
During study clinic stays and study visits, the study team will collect urine and blood samples and perform safety reviews. If only Part 1 is conducted, total time in the study (screening (start) through follow-up (end)) will be about 14 weeks. If both Part 1 and Part 2 are conducted, total time in the study will be about 22 weeks.
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1
The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body.
Period 2
Compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Period 3 (Optional)
Assess how PF-07328948 acts after taking it daily until the body reaches a steady level.
Period 4 (Optional)
Check again how much PF-07328948 is absorbed and leaves the body after daily dosing.
What Are the Treatments Tested in This Trial?
Interventions
- PF-07328948
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets
Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month
Participants will receive a single tablet of unlabeled oral dose of PF-07328948; \~ 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948
Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension.
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
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