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

NCT04266509 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79810262019-004643-72
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

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

  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.

Study Arms (1)

Rifampin and PF-06651600 DDI

EXPERIMENTAL

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; Drug: Rifampin

Interventions

PF-06651600 DRUG

50 milligram (mg) tablet

Rifampin and PF-06651600 DDI

Rifampin DRUG

600 mg provided as two 300 mg capsules.

Also known as: Rifadin®.

Rifampin and PF-06651600 DDI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

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

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06651600; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: June 25, 2020
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)