NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04866225

CompletedPhase 1

Sponsor: Pfizer

Conditions: Healthy Participants

Interventions: Oral [14C]PF-06865571, Oral PF-06865571, IV [14C]PF-06865571

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Madison, Wisconsin, United States