Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sitaxsentan

Group Type ACTIVE_COMPARATOR

Sitaxsentan alone

Intervention Type DRUG

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

Sitaxsentan plus Rifampin

Group Type EXPERIMENTAL

Sitaxsentan

Intervention Type DRUG

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

Rifampin

Intervention Type DRUG

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

Interventions

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Sitaxsentan alone

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

Intervention Type DRUG

Sitaxsentan

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

Intervention Type DRUG

Rifampin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes