Drug Interaction Between Ritonavir And Sitaxsentan

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01251848

Enrollment

Registered

2010-12-02

Start date

2011-01-31

Completion date

2011-02-28

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Sitaxentan, ritonavir, drug interaction, pharmacokinetics

Brief summary

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

Interventions

DRUGSitaxentan

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

DRUGRitonavir

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

DRUGSitaxsentan

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026