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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2024-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Understand How the Body Processes [14C]PF-07104091 in Healthy Participants

NCT07127770

Healthy Adults

COMPLETED PHASE1

A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults

NCT06267963

Healthy Participants

COMPLETED PHASE1

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

NCT04495140

Healthy Volunteer

COMPLETED PHASE1

A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men

NCT07015918

Healthy Male Volunteers

COMPLETED PHASE1

Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants

NCT05050682

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Participants will receive one dose of \[14C\] PF-06821497 by mouth in Period 1. After a washout, participants will receive one dose of PF-06821497 by mouth and one intravenous (IV) infusion of \[14C\] PF-06821497 in Period 2

Group Type EXPERIMENTAL

Oral [14C] PF-06821497

Intervention Type DRUG

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

Oral PF-06821497

Intervention Type DRUG

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

IV [14C] PF-06821497

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral [14C] PF-06821497

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

Intervention Type DRUG

Oral PF-06821497

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male participants aged 18 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body mass index (BMI) of 16-32 kg/m2; and a total body weight of \>50kg (110lb)
* Participants who are willing to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria

* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, prior bariatric surgery, ileal resection, inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease).
* Chronic liver diseases including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus, or other chronic liver disease.
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) 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 their participation in this study.
* Total \[14C\] radioactivity measured in plasma at screening exceeding 11 mBq/mL

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes