Drug Interaction Between Ritonavir And Sitaxsentan

Phase 1WithdrawnNCT01251848

Pfizer

Overview

The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Pulmonary Arterial Hypertension

Interventions

SitaxentanDRUG

Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.

RitonavirDRUG

Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).

SitaxsentanDRUG

Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days

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 (because of teratogenic risk of sitaxsentan) 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. * History of significant alcohol and drug use. * Has hepatic dysfunction.

Outcomes

Primary Outcomes

The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.

Time frame: 24 hours

The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.

Time frame: 24 hours

The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.

Time frame: 24 hours

The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.

Time frame: 24 hours

Data from ClinicalTrials.gov

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