NCT04495140

Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral \[14C\]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of \[14C\]PF-06882961 in reference to intravenous \[14C\]PF-06882961 in healthy male participants.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	[14C]PF-06882961, 50 mg	A single oral dose of \[14C\]PF-06882961, will be administered as a liquid formulation.
DRUG	PF-06882961, 50 mg and [14C]PF-06882961, 100 ug	A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961 will be administered via intravenous infusion.

Timeline

• Start date: 2020-07-22
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2020-07-31
• Last updated: 2020-11-25

Locations

2 sites across 1 country: Netherlands

Regulatory

• FDA-regulated drug study