A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06463922; Drug: rifampin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02804399

RIFAMPIN DDI STUDY (Other Identifier)

B7461011

Details and patient eligibility

About

The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.

Full description

This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study in approximately 12 healthy subjects employing administration of a single oral dose of PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Any condition possibly affecting drug absorption
• Positive urine drug screen
• History of HIV, Hep B or Hep C
• History of regular alcohol consumption
• History of cardiac arrhythmia, history of AV block, history of symptomatic bradycardia, history of QTc prolongation
• History of pancreatitis or hyperlipidemia, elevated lipase

Trial design

12 participants in 1 patient group

all subjects

Experimental group

Description:

subjects will receive a 100 mg single oral dose of PF-06463922 followed by a 100 mg single dose of PF-06463922 combined with 600 mg QD dose of rifampin with at least 10 days of washout period between two PF-06463922 doses.

Treatment:

Drug: rifampin

Drug: PF-06463922