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Completed

NCT Number: NCT03929510

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.

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

14C-PF-06651600

Drug

Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity

14C-PF-06651600 IV

Drug

IV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity

PF-06651600

Drug

Oral solution 200mg

Primary outcomes

  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 outcomes

  1. Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma

    Time frame: Hour 0 up to 312 hours post-dose.

  2. Amount (% of the administered dose) of major metabolites of PF-06651600 in urine

    Time frame: Hour 0 up to 312 hours post-dose.

  3. Amount (% of the administered dose) of major metabolites of PF-06651600 in feces

    Time frame: Hour 0 up to 312 hours post-dose.

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: B7981011

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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