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Trial record 1 of 1 for:    NCT04495140
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Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

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ClinicalTrials.gov Identifier: NCT04495140
Recruitment Status : Completed
First Posted : July 31, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 16, 2020
First Posted Date  ICMJE July 31, 2020
Last Update Posted Date November 25, 2020
Actual Study Start Date  ICMJE July 22, 2020
Actual Primary Completion Date October 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1 [ Time Frame: Baseline through approximately hour 312 (day 14). Period 1 is 14 days ]
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
  • Metabolite profiling/identification in plasma, urine, and feces [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr) ]
    Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces.
  • Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Maximum Observed Plasma Radioactivity
  • Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Time to Reach Maximum Observed Plasma Radioactivity
  • Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Area under the plasma radioactivity-time profile from time 0 to time of the last quantifiable concentration (Clast)
  • Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
  • Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
  • Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Maximum Observed Plasma Concentration
  • Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Time to Reach Maximum Observed Plasma Concentration
  • Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast)
  • Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
  • Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961 [ Time Frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr ]
    where MRT is the Mean Residence Time
  • Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961 [ Time Frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr ]
    Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body.
  • Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961 [ Time Frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
  • Absolute oral bioavailability (F) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961
  • Fraction of dose absorbed following single oral administration of [14C]PF-06882961 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr ]
    Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration
  • Number of participants with adverse events [ Time Frame: Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days ]
    adverse events
  • Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961 [ Time Frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr ]
    Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
  • Number of participants with safety laboratory test results above/below certain threshold [ Time Frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days) ]
    lab tests
  • Number of participants with ECG measurements above/below certain threshold [ Time Frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days) ]
    ECGs
  • Number of participants with vital measurements above/below certain threshold [ Time Frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days) ]
    vitals
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2020)
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:

  • 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 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
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/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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