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.

NCT03929510 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79810112018-003551-38
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Keywords

Phase 1; Male; healthy

Outcome Measures

Primary Outcomes (2)

• Mass Balance: Cumulative recovery (%) of radioactivity in urine

  Cumulative recovery (%) of radioactivity in urine.

  from time zero to the time of last measurable concentration following oral administration of 14C PF-06651600 microtracer dose up to day 24

• Mass Balance: Cumulative recovery (%) of radioactivity in feces

  Cumulative recovery (%) of radioactivity in feces

  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 (18)

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

  Hour 0 up to 312 hours post-dose.

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

  Hour 0 up to 312 hours post-dose.

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

  Hour 0 up to 312 hours post-dose.

• Cmax

  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

• AUClast

  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

Study Arms (2)

Period A

EXPERIMENTAL

Single oral dose of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi 14C (ie, radiolabeled PF 06651600).

Drug: 14C-PF-06651600

Period B

EXPERIMENTAL

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; Drug: PF-06651600

Interventions

14C-PF-06651600 DRUG

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

Period A

14C-PF-06651600 IV DRUG

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

Period B

PF-06651600 DRUG

Oral solution 200mg

Period B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only Male participants will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

PRA Health Sciences Utrecht

Utrecht, 3584 BL, Netherlands

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06651600

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 29, 2019
• Study Start: April 23, 2019
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)