- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495140
Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961
November 23, 2020 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Groningen, Netherlands, 9728 NZ
- PRA Health Sciences
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Utrecht, Netherlands, 3584 BL
- PRA Health Sciences Utrecht
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 54 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
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Baseline through approximately hour 312 (day 14). Period 1 is 14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces.
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)
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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
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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Time to Reach Maximum Observed Plasma Radioactivity
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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)
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
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00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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Maximum Observed Plasma Concentration
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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Time to Reach Maximum Observed Plasma Concentration
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast)
|
0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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where MRT is the Mean Residence Time
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0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
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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
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Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
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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
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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.
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0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
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Absolute oral bioavailability (F)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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
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Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration
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0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr
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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
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adverse events
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Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days
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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
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Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
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00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
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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)
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lab tests
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baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
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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)
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ECGs
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baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
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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)
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vitals
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baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2020
Primary Completion (Actual)
October 15, 2020
Study Completion (Actual)
October 15, 2020
Study Registration Dates
First Submitted
July 16, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
November 25, 2020
Last Update Submitted That Met QC Criteria
November 23, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C3421009
- 2019-002584-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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