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OpenTrials
Completed

NCT Number: NCT06392230

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key eligibility criteria for this study include, but are not limited to the following:

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

Treatment and study plan

Oral [14C] PF-06821497

Drug

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

Oral PF-06821497

Drug

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

IV [14C] PF-06821497

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

Primary outcomes

  1. Total recovery of radioactivity in urine, feces, and total excreta (urine + feces) as percentage of total radioactive dose administered

    Time frame: Period 1 pre-dose to maximum Day 14

    To characterize the extent of excretion of total radioactivity in urine and feces following administration of a single oral dose of [14C]PF-06821497

  2. Metabolic profiling/identification and determination of relative abundance of [14C]PF-06821497 and the metabolites of [14C]PF-06821497 in plasma, urine, and feces

    Time frame: Period 1 pre-dose to maximum Day 14

    Amount of metabolites of [14C]PF-06821497 in plasma, urine, and feces

Secondary outcomes

  1. Absolute oral bioavailability (F) of [14C]PF-06821497

    Time frame: Period 2 pre-dose to maximum Day 5

    To determine the absolute oral bioavailability (F) of PF-06821497 by comparing AUCinf following administration of a single oral dose of PF-06821497 to a single IV microtracer of [14C]PF 06821497

  2. Fraction of [14C]PF 06821497 dose absorbed (Fa)

    Time frame: Period 1 pre-dose to maximum Day 14; Period 2 pre-IV dose to maximum Day 5

    To determine the fraction of the dose absorbed (Fa) following administration of a single oral dose of [14C]PF 06821497 from total urinary radioactivity of [14C]PF 06821497 in Period 1 and IV microtracer microdose administration of [14C]PF 06821497 in Period 2

  3. AUClast of total radioactivity and PF-06821497 in plasma

    Time frame: Period 1 pre-dose to maximum Day 14

    To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.

  4. Cmax of total radioactivity and PF-06821497 in plasma

    Time frame: Period 1 pre-dose to maximum Day 14

    To quantify plasma peak concentration (Cmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.

  5. Tmax of total radioactivity and PF-06821497 in plasma

    Time frame: Period 1 pre-dose to maximum Day 14

    To quantify plasma time of peak concentration (Tmax) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.

  6. AUCinf of total radioactivity and PF-06821497 in plasma

    Time frame: Period 1 pre-dose to maximum Day 14

    If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.

  7. t½ of total radioactivity and PF-06821497 in plasma

    Time frame: Period 1 pre-dose to maximum Day 14

    If data permits, to quantify plasma half-life (t½) of PF-06821497 and total radioactivity following administration of a single oral dose of [14C]PF-06821497.

  8. AUClast of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    To quantify plasma area under the concentration versus time curve (AUClast) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  9. Cmax of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    To quantify plasma peak concentration (Cmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  10. Tmax of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    To quantify plasma time of peak concentration (Tmax) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  11. t½ of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    If data permits, to quantify plasma half-life (t½) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  12. AUCinf of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    If data permits, to quantify plasma area under the concentration versus time curve extrapolated to infinity (AUCinf) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  13. CL of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    If data permits, to quantify plasma clearance (CL) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  14. Vss of [14C]PF-06821497 in plasma

    Time frame: Period 2 pre-dose to maximum Day 5

    If data permits, to quantify plasma volume of distribution at steady-state (Vss) of PF-06821497 following administration of a single, IV, microtracer of [14C]PF-06821497.

  15. Number of participants with treatment emergent clinically significant laboratory abnormalities

    Time frame: Both cohorts from pre-dose to 28 days post-dose

  16. Number of participants with treatment emergent clinically significant abnormal ECG measurements

    Time frame: Both cohorts from pre-dose to 28 days post-dose

  17. Number of participants with treatment emergent clinically significant abnormal vital measurements

    Time frame: Both cohorts from pre-dose to 28 days post-dose

  18. Number of participants with treatment emergent clinically significant abnormal physical examination

    Time frame: Both cohorts from pre-dose to 28 days post-dose

  19. Number of participants with treatment-emergent adverse events (AEs) or serious adverse events (SAEs)

    Time frame: Both cohorts from pre-dose to 28 days post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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-06821497 USING A 14C-MICROTRACER APPROACH

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2024
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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