A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2021-08-06

Brief Summary

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This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of \[14C\]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration of unlabeled PF-06865571 and IV administration of \[14C\]PF-06865571.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study arm

One arm of healthy male participants administered a single oral dose of \[14C\]PF-06865571; followed by a single dose of unlabeled PF-06865571, and IV administration of \[14C\]PF-06865571 three hours later.

Group Type EXPERIMENTAL

Oral [14C]PF-06865571

Intervention Type DRUG

Oral radiolabeled PF-06865571

Oral PF-06865571

Intervention Type DRUG

Oral PF-06865571

IV [14C]PF-06865571

Intervention Type DRUG

IV radiolabeled PF-06865571

Interventions

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Oral [14C]PF-06865571

Oral radiolabeled PF-06865571

Intervention Type DRUG

Oral PF-06865571

Intervention Type DRUG

IV [14C]PF-06865571

IV radiolabeled PF-06865571

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male participants, 18 to 60 years of age, inclusive, at the time of signing the informed consent document.
* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests.
* Participants who are nonsmoking for at least 3 months at the time of signing the informed consent document.
* BMI of 17.5 to 30.4 kg/m2, inclusive; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation, defined by less than 1 bowel movement on average per 2 days, or lactose intolerance.
* History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,or HCVAb. Hepatitis B vaccination is allowed.
* History of SARS-CoV-2 PCR or antibody (eg, IgG, IgM, etc) positive result would necessitate accompanying history of asymptomatic state for at least 6 months prior to screening.
* Use of prescription or nonprescription drugs.
* Previous administration with an unapproved drug within 60 days preceding the first dose of study intervention used in this study.
* A positive urine drug test.
* A positive urine cotinine test.
* A positive COVID-19 (SARS-CoV-2) PCR test.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes