Drug Interaction Between Ritonavir And Sitaxsentan

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01251848
• Other study ID #: B1321061
• Status: Withdrawn
• Phase: Phase 1
• First received: December 1, 2010
• Last updated: March 4, 2015
• Start date: January 2011
• Est. completion date: February 2011

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Sitaxentan
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
• Ritonavir
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
• Sitaxsentan
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days
• Ritonavir
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.		24 hours	No
Primary	The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.		24 hours	No
Primary	The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.		24 hours	No
Primary	The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.		24 hours	No

External Links

•   To obtain contact information for a study center near you, click here.