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

NCT04495140

Last updated date
Study Location
PRA Health Sciences
Groningen, , 9728 NZ, Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-54 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: [14C]PF-06882961, 50 mg
    A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: [14C]PF-06882961, 50 mg
  • Experimental: 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.
    Intervention: Drug: PF-06882961, 50 mg and [14C]PF-06882961, 100 ug
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2020)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2020
Estimated Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 54 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP