Clinical trial 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Phase 1
Male
healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Mass Balance: Cumulative recovery (%) of radioactivity in urine
timeFrame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24
measure: Mass Balance: Cumulative recovery (%) of radioactivity in feces
timeFrame: from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24
Secondary outcomes:
measure: Amount (% of the administered dose) of major metabolites of PF-06651600 in plasma
timeFrame: Hour 0 up to 312 hours post-dose.
measure: Amount (% of the administered dose) of major metabolites of PF-06651600 in urine
timeFrame: Hour 0 up to 312 hours post-dose.
measure: Amount (% of the administered dose) of major metabolites of PF-06651600 in feces
timeFrame: Hour 0 up to 312 hours post-dose.
measure: Cmax
timeFrame: 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
measure: AUClast
timeFrame: 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
measure: AUCinf
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: t1/2
timeFrame: 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
measure: CL (IV)
timeFrame: 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
measure: CL/F (oral)
timeFrame: 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
measure: Vss
timeFrame: 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
measure: Vz/F
timeFrame: 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
measure: Total 14C_Urine_PO
timeFrame: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose
measure: Total 14C_Urine_IV
timeFrame: Pre-dose, Day1, day 2, day 3, day 4, day 5, day 6 and day 7 post-dose
measure: AE
timeFrame: Baseline (Day 0) up to 90 days after last dose of study medication
measure: Number of participants with clinically significant changes to the physical examination
timeFrame: Baseline (Day 0) up to Day 24
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline (Day 0) up to Day 24
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
timeFrame: Baseline (Day 0) up to Day 24
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
city: Utrecht
country: Netherlands
facility: PRA Health Sciences Utrecht
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: