Status:
COMPLETED
Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-54 years
Phase:
PHASE1
Brief Summary
This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral \[14C\]PF-06882961 and to evaluate the absolut...
Eligibility Criteria
Inclusion
- Male participants between 18 to 54 years of age
- Healthy and capable of signing informed consent document
- Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures
- Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).
Exclusion
- acute or chronic medical or psychiatric condition including recent (within the past year)
- Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements
- Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days prior to the first dose of investigational product.
- Previous administration with an investigational drug within 60 days (or as determined by the local requirement) preceding the first dose of investigational product used in this study.
- Known prior participation in a trial involving PF-06882961 or known intolerance to a GLP-1R agonist.
- A positive urine drug test on screening or Day -1.
- Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- Participants with abnormalities in clinical laboratory tests including ECGs, vital signs, liver function tests, myocardial infarction
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- History of alcohol or tobacco abuse or binge drinking and/or any other illicit drug use or dependence within past 6 months.
- Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin is planned to flush intravenous catheters.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04495140
Start Date
July 22 2020
End Date
October 15 2020
Last Update
November 25 2020
Active Locations (2)
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1
PRA Health Sciences
Groningen, Netherlands, 9728 NZ
2
PRA Health Sciences Utrecht
Utrecht, Netherlands, 3584 BL