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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04266509

Enrollment

Registered

2020-02-12

Start date

2020-06-25

Completion date

2020-09-10

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

PF-06651600, Rifampin, Drug-drug interaction study, Pharmacokinetics

Brief summary

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

Interventions

DRUGPF-06651600

50 milligram (mg) tablet

DRUGRifampin

600 mg provided as two 300 mg capsules.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026