A Study to Understand How a Study Medicine Called PF-07328948 is Absorbed and Processed in the Body of Healthy Male Adults

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Pfizer
Study ID
NCT07508228
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Oral [14C]PF-07328948 — DRUG
    A single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional)
  • Oral Unlabeled PF-07328948 — DRUG
    A single unlabeled oral dose of PF-07328948 administered as a tablet. Approximately 3 hours post-dose, participants will receive a single IV infusion of \[14C\]PF-07328948 Period 2: single dose, Period 3: QD Period 4: (Day 2 - mass balance completion)
  • IV [14C]PF-07328948 — DRUG
    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 administered as tablets.

Study Details

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.

Key Dates

Start date
Apr 3, 2026
Status verified
May 2026
Primary completion
Sep 24, 2026
Completion
Sep 24, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Period 1/Treatment A
    Participants will receive a single oral dose of \[14C\]PF-07328948 administered as an extemporaneously prepared oral suspension.
  • Experimental: Period 2/Treatment B
    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
  • Experimental: Period 3/Treatment C
    Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month
  • Experimental: Period 4/Treatment D
    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

Primary Outcome Measure

Total recovery of radioactivity in urine, feces, expired air (if analyzed and if reportable), and emesis (if any), and all routes combined, expressed as a percentage of oral radioactive dose administered. [ Time Frame: Period 1 pre-dose to maximum Days 22 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research Unit Inc.MadisonWisconsin53704-

Find similar trials in Madison, WI

By research site
Fortrea Clinical Research Unit Inc.· Madison, WI

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