How PF-07328948 is absorbed and cleared in healthy adult men
A PHASE 1, OPEN-LABEL, 4-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07328948 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07328948 IN HEALTHY MALE ADULT PARTICIPANTS USING A [14C]-MICROTRACER APPROACH
This test looks at how a dose of PF-07328948 gets into the bloodstream and is removed from the body in healthy men aged 18 to 64.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Male |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07508228 on ClinicalTrials.gov |
What this trial studies
This Phase 1, two-part, four-period study uses radiolabeled [14C] PF-07328948 given orally and by IV to measure absorption, distribution, metabolism, and excretion in healthy male volunteers. Part 1 includes single-dose oral and IV periods to determine systemic exposure and relative bioavailability, and Part 2 (optional) includes repeated daily dosing to reach steady state with additional ADME sampling. Frequent blood and urine collections are performed during clinic stays and visits to quantify radioactivity and parent drug levels. Results will be used to characterize how the drug is handled by the body and to inform dosing and safety for later clinical development.
Who should consider this trial
Good fit: Healthy males aged 18–64 years with BMI 17.5–32 kg/m2 and body weight >50 kg who have no significant medical conditions and meet screening lab, ECG, and background radioactivity limits.
Not a fit: Women, people with significant medical illnesses, those with elevated background radioactivity, or recent participation in other investigational product studies are not eligible and would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, the results will clarify how PF-07328948 is processed in humans and help set safe dosing and monitoring strategies for future patient studies.
How similar studies have performed: Radiolabeled ADME ([14C]) studies are a common, well-established method that has been successfully used to characterize human pharmacokinetics for many drugs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male participants aged ≥18 years to \<65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. * BMI of 17.5-32 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Criteria * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease. * 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. * Background radioactivity measured in plasma and/or urine at screening exceeding an F14C value of 2.5. * Prior participation in a radiolabeled ADME clinical study within 12 months prior to screening.
Where this trial is running
Madison, Wisconsin
- Fortrea Clinical Research Unit Inc. — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.