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

NCT04266509 — Phase 1, Completed, 12 participants, Pfizer

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PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF REPEAT-DOSE RIFAMPIN ON THE PHARMACOKINETICS OF PF-06651600 IN HEALTHY PARTICIPANTS

Registry	NCT04266509
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: none, basic science
Enrollment	12 (Actual)
Sponsor	Pfizer (Industry)
Conditions	Healthy Volunteers
Interventions	PF-06651600, Rifampin (Drug)
Dates	start 2020-06-25, primary completion 2020-09-10, completion 2020-09-10, first posted 2020-02-12, last updated 2020-09-16
Locations	1 site in Belgium

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Rifampin and PF-06651600 DDI	Experimental	Drug: PF-06651600; Drug: Rifampin	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.

PF-06651600 (Drug): 50 milligram (mg) tablet
Rifampin (Drug), also known as Rifadin®.: 600 mg provided as two 300 mg capsules.

+Outcome measures

Primary outcomes

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.]
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

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Brussels Clinical Research Unit	Brussels, Bruxelles-capitale, Région de	Belgium

+Investigators

Pfizer CT.gov Call Center, Study director, Pfizer

+Funding

NIH grants: 2019