Drug Interaction Between Ritonavir And Sitaxsentan
Phase 1
Withdrawn
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Registration Number
- NCT01251848
- Lead Sponsor
- Pfizer
- Brief Summary
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C Ritonavir - Treatment A Sitaxentan - Treatment B Ritonavir - Treatment C Sitaxsentan -
- Primary Outcome Measures
Name Time Method The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. 24 hours The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. 24 hours The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone. 24 hours The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone. 24 hours
- Secondary Outcome Measures
Name Time Method