Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961
NCT04495140
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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).
- 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.
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Descriptive Information | |||||
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Brief Title ICMJE | Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961 | ||||
Official Title ICMJE | A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||
Condition ICMJE | Healthy Volunteer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 6 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | October 15, 2020 | ||||
Actual Primary Completion Date | October 15, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 54 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04495140 | ||||
Other Study ID Numbers ICMJE | C3421009 2019-002584-10 ( EudraCT Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |