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Completed

NCT Number: NCT04266509

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06651600

Drug

50 milligram (mg) tablet

Rifampin

Drug

600 mg provided as two 300 mg capsules.

Other names: Rifadin®.

Primary outcomes

  1. Cmax (maximum plasma concentration) of PF-06651600

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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