MedTrace Logo

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

NCT04495140 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-11-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2020-10-15
Completion
2020-10-15
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495140 on ClinicalTrials.gov