Drug Interaction Between Ritonavir And Sitaxsentan

March 4, 2015 updated by: Pfizer

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Time Frame: 24 hours
24 hours
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Time Frame: 24 hours
24 hours
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Time Frame: 24 hours
24 hours
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 1, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1321061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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