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Study to Evaluate the Effect of Repeat-Dose Rifampin on the Pharmacokinetics (PK) of PF-06651600

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04266509
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
2.5
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study to Evaluate the Effect of Repeat-Dose Rifampin on the pharmacokinetics (PK) of PF-06651600.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF REPEAT-DOSE RIFAMPIN ON THE PHARMACOKINETICS OF PF-06651600 IN HEALTHY PARTICIPANTS
Actual Study Start Date :
Jun 25, 2020
Actual Primary Completion Date :
Sep 10, 2020
Actual Study Completion Date :
Sep 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rifampin and PF-06651600 DDI

In Period 1, participants will receive a single oral 50 mg dose of PF-06651600. In Period 2, participants will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, in the morning of Day 8 participants will be administered with rifampin 600 mg 2 hour prior to administration of a single 50 mg oral dose of PF-06651600.

Drug: PF-06651600
50 milligram (mg) tablet

Drug: Rifampin
600 mg provided as two 300 mg capsules.
Other Names:
  • Rifadin®.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax (maximum plasma concentration) of PF-06651600 [Hour 0, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post post Period 1, Day 1, Period 2, Day 8.]

    2. AUC (Area under the curve) of PF-06651600 [Hour 0, and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post post Period 1, Day 1, Period 2, Day 8.]

      Area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes BP and pulse rate measurements, clinical laboratory tests, and 12-lead ECG.

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

    Exclusion Criteria:

    • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

    • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

    • Systemic therapy with any of the medications that are moderate or strong CYP3A4 and/or CYP2C19 inhibitors within 28 days or 5 half-lives (whichever is longer) or moderate or strong CYP3A and/or CYP2C19 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.

    • Known participation in a clinical trial of PF-06651600 within 60 days prior to the first dose of investigational product; participation in any clinical trail of PF-06651600 and the participant experienced AE that led to discontinuation, or had SAE, that in the judgment of the investigator were PF-06651600-related.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brussels Clinical Research Unit Brussels Bruxelles-capitale, Région DE Belgium B-1070

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04266509
    Other Study ID Numbers:
    • B7981026
    • 2019-004643-72
    First Posted:
    Feb 12, 2020
    Last Update Posted:
    Sep 16, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pfizer
    PF-06651600
    Rifampin
    Drug-drug interaction study
    Pharmacokinetics
    Additional relevant MeSH terms:
    Rifampin

    Study Results

    No Results Posted as of Sep 16, 2020