Status:
COMPLETED
A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04866225
Start Date
May 11 2021
End Date
August 6 2021
Last Update
July 31 2024
Active Locations (1)
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1
Labcorp Clinical Research Unit
Madison, Wisconsin, United States, 53704