Drug Interaction Between Ritonavir And Sitaxsentan

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Sitaxentan; Drug: Ritonavir; Drug: Sitaxsentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01251848

B1321061

Details and patient eligibility

About

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

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 (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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Treatment A

Active Comparator group

Treatment:

Drug: Sitaxentan

Treatment B

Active Comparator group

Treatment:

Drug: Ritonavir

Drug: Ritonavir

Treatment C

Experimental group

Treatment:

Drug: Sitaxsentan

Drug: Ritonavir

Drug: Ritonavir