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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT04866225

Run by

Pfizer

People needed

6

Starts

2021-05-11

Expected to finish

2021-08-06

Last updated by the study team

2024-07-31

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Labcorp Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.