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A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body.

NCT06392230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-01-23

No results posted yet for this study

Summary

The purpose of this study is to learn how a certain amount of \[14C\] PF-06821497 is taken up into the bloodstream and removed from the body.

The study is seeking participants who are:

* Males aged 18 years or older.
* Are confirmed to be healthy after performing some medical and physical tests.
* Weigh more than 50 kilograms and have a body mass index of 16 to 32 kg per meter squared.

The study consists of two parts. In part one, all participants will receive one full dose of \[14C\]PF-06821497 by mouth. Part two will begin at least 14 days after the dose in part one. In part two participants will receive one full dose of PF-06821497 by mouth and one small dose of \[14C\]PF-06821497 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.

To understand how the medicine is processed in the body, samples of blood, urine, and feces will be collected after each dose is given. This will help understand:

* How much PF-06821497 is taken up into the bloodstream when taken by mouth compared to the dose given by IV
* How the body removes it from the bloodstream.

Participants will take part in the study for about 11 weeks, including the initial evaluation and follow-up periods.

Conditions

  • Healthy Participants

Interventions

DRUG

Oral [14C] PF-06821497

A single oral dose of \[14C\] PF-06821497 will be administered as an extemporaneous suspension in Period 1

DRUG

Oral PF-06821497

A single oral dose of PF-06821497 will be administered as an extemporaneous oral suspension in Period 2

DRUG

IV [14C] PF-06821497

A single IV infusion of \[14C\] PF-06821497 will be administered at the Tmax after administration of the unlabeled oral dose of PF-06821497 in Period 2

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2024-11-11
Completion
2024-11-11

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 NCT06392230 on ClinicalTrials.gov