Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Pfizer

Overview

This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Pulmonary Arterial Hypertension

Interventions

Sitaxsentan aloneDRUG

Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)

SitaxsentanDRUG

Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)

RifampinDRUG

Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects and/or women of non-child bearing potential. * Subjects between the ages of 21 and 55 years, inclusive. * Signed informed consent. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * Has hepatic dysfunction. * Has history of excessive alcohol and tobacco use.

Outcomes

Primary Outcomes

Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.

Time frame: 24 hours

Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.

Time frame: 24 hours

Data from ClinicalTrials.gov

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