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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Study to Characterize Absorption, Distribution, Metabolism and Excretion of 14C PF-06651600 and to Evaluate the Absolute Oral Bioavailability and Fraction Absorbed of PF-06651600.

Clinicaltrials.gov identifier NCT03929510

Recruitment Status Completed

First Posted April 29, 2019

Last update posted July 24, 2019

Study Description

Brief summary:

This study will investigate the absorption, distribution, metabolism and excretion (ADME) of 14C PF-06651600 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-06651600 in humans.

  • Condition or Disease:Healthy Volunteers
  • Intervention/Treatment: Drug: 14C-PF-06651600
    Drug: 14C-PF-06651600 IV
    Drug: PF-06651600
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 6 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • Official Title: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06651600 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06651600 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: July 2019
  • Actual Study Completion Date: July 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Period A
Single oral dose of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF 06651600).
Drug: 14C-PF-06651600
Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
Experimental: Period B
Single oral dose of 200 milligrams (mg) unlabeled PF-06651600 followed at time of peak plasma concentration (Tmax) by an Intravenous (IV) dose of 60 micrograms.14C -PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF-06651600).
Drug: 14C-PF-06651600 IV
IV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity

Drug: PF-06651600
Oral solution 200mg
Outcome Measures
  • Primary Outcome Measures: 1. Mass Balance: Cumulative recovery (%) of radioactivity in urine [ Time Frame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24 ]
    Cumulative recovery (%) of radioactivity in urine.
  • 2. Mass Balance: Cumulative recovery (%) of radioactivity in feces [ Time Frame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24 ]
    Cumulative recovery (%) of radioactivity in feces
  • Secondary Outcome Measures: 1. Vss [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Steady state volume of distribution following IV infusion
  • 2. Vz/F [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Apparent volume of distribution following oral administration
  • 3. Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma [ Time Frame: Hour 0 up to 312 hours post-dose. ]
  • 4. Amount (% of the administered dose) of major metabolites of PF-06651600 in urine [ Time Frame: Hour 0 up to 312 hours post-dose. ]
  • 5. Amount (% of the administered dose) of major metabolites of PF-06651600 in feces [ Time Frame: Hour 0 up to 312 hours post-dose. ]
  • 6. Cmax [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Maximum plasma concentration
  • 7. AUClast [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration (Clast)
  • 8. AUCinf [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Area under the plasma concentration time profile from time 0 to infinity
  • 9. Tmax [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Time for Cmax
  • 10. t1/2 [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • 11. CL (IV) [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
  • 12. CL/F (oral) [ Time Frame: Pre-dose, 0.25. 0.5, 1, 1.5, 2, 3.5, 4.5, 6.5, 8.5, 12.5, 24, 48, 72, 96 hours post-dose ]
    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
  • 13. Total 14C_Urine_PO [ Time Frame: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose ]
    Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following oral administration of 14C PF 06651600 microtracer dose
  • 14. Total 14C_Urine_IV [ Time Frame: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose ]
    Total radioactivity excreted into the urine from time zero to the time of last measurable concentration following IV administration of 14C PF 06651600 microtracer dose
  • 15. AE [ Time Frame: Baseline (Day 0) up to 90 days after last dose of study medication ]
    Number of subjects and number of AEs which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug.
  • 16. Number of participants with clinically significant changes to the physical examination [ Time Frame: Baseline (Day 0) up to Day 24 ]
    clinically significant changes to the physical examination
  • 17. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline (Day 0) up to Day 24 ]
    Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) obtained from each participant. Clinical significance of vital signs was determined at the investigator's discretion.
  • 18. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline (Day 0) up to Day 24 ]
    Laboratory parameters include: hematological and chemical parameters
Eligibility Criteria
  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Male participants who are healthy as determined by medical evaluation including a
detailed medical history, full physical examination, including blood pressure (BP) and
pulse rate (PR) measurement, 12 lead ECG, and clinical laboratory tests.

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

- Known immunodeficiency disorder, including positive serology for human
immunodeficiency virus (HIV) at screening, or a first degree relative with a
hereditary immunodeficiency.

- Infection with hepatitis B or hepatitis C viruses.

- Participants with selected acute or chronic infections or infection history.

- Participants have a known present or a history of malignancy other than a successfully
treated or excised non metastatic basal cell or squamous cell cancer of the skin.

- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.

- Use of tobacco/nicotine containing products within 3 months prior to dosing or
positive urine cotinine test.

Contacts and Locations
Contacts
Locations

Netherlands
PRA Health Sciences
Groningen

Netherlands
PRA Health Sciences Utrecht
Utrecht

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center Pfizer

More Information
  • Responsible Party: Pfizer
  • ClinicalTrials.gov Identifier: NCT03929510 History of Changes
  • Other Study ID Numbers: B7981011, 2018-003551-38
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: July 24, 2019
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Pfizer: Phase 1
    Male
    healthy