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Trial record 5 of 15 for:    PF-06651600

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. (B7981011)

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ClinicalTrials.gov Identifier: NCT03929510
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 Intervention/treatment Phase
Healthy Volunteers Drug: 14C-PF-06651600 Drug: 14C-PF-06651600 IV Drug: PF-06651600 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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 23, 2019
Estimated Primary Completion Date : July 11, 2019
Estimated Study Completion Date : July 11, 2019

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




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. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only Male participants will be enrolled.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929510


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Netherlands
PRA Health Sciences Recruiting
Groningen, Netherlands, 9728 NZ
PRA Health Sciences Utrecht Recruiting
Utrecht, Netherlands, 3584 BL
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03929510     History of Changes
Other Study ID Numbers: B7981011
2018-003551-38 ( EudraCT Number )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 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.

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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