Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

NCT ID: NCT04495140

Last Updated: 2020-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2020-10-15

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 absolute oral bioavailability of PF-06882961 and fraction absorbed of [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.

Conditions

Healthy Volunteer

Keywords

bioavailability; excretion; metabolism; absorption

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Oral [14C]PF-06882961, 50 mg

In this arm, a single oral dose of \[14C\]PF-06882961, 50 mg will be administered as a liquid formulation.

Group Type: EXPERIMENTAL

[14C]PF-06882961, 50 mg

Intervention Type: DRUG

A single oral dose of \[14C\]PF-06882961, will be administered as a liquid formulation.

Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug

In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961, 100 ug, will be administered via intravenous infusion.

Group Type: EXPERIMENTAL

PF-06882961, 50 mg and [14C]PF-06882961, 100 ug

Intervention Type: DRUG

A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961 will be administered via intravenous infusion.

Interventions

[14C]PF-06882961, 50 mg

A single oral dose of \[14C\]PF-06882961, will be administered as a liquid formulation.

Intervention Type: DRUG

PF-06882961, 50 mg and [14C]PF-06882961, 100 ug

A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961 will be administered via intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

PRA Health Sciences

Groningen, , Netherlands

PRA Health Sciences Utrecht

Utrecht, , Netherlands

Countries

Netherlands

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3421009

To obtain contact information for a study center near you, click here.

Other Identifiers

2019-002584-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3421009

Identifier Type: -

Identifier Source: org_study_id