Drug Interaction Between Ritonavir And Sitaxsentan

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01251848

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: Sitaxentan Drug: Ritonavir Drug: Sitaxsentan Drug: Ritonavir	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Feb 1, 2011

Anticipated Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A	Drug: Sitaxentan Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
Active Comparator: Treatment B	Drug: Ritonavir Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
Experimental: Treatment C	Drug: Sitaxsentan Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days Drug: Ritonavir Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days

Arm

Intervention/Treatment

Active Comparator: Treatment A

Drug: Sitaxentan

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

Active Comparator: Treatment B

Drug: Ritonavir

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

Experimental: Treatment C

Drug: Sitaxsentan

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

Drug: Ritonavir

Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days

Outcome Measures

Primary Outcome Measures

The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone. [24 hours]
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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.