Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Sitaxsentan alone; Drug: Rifampin; Drug: Sitaxsentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251835

B1321060

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Sitaxsentan

Active Comparator group

Treatment:

Drug: Sitaxsentan alone

Sitaxsentan plus Rifampin

Experimental group

Treatment:

Drug: Sitaxsentan

Drug: Rifampin