Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

March 4, 2015 updated by: Pfizer

A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects

This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.

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Withdrawn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 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.
  • Has hepatic dysfunction.
  • Has history of excessive alcohol and tobacco use.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sitaxsentan
Drug: Sitaxsentan alone
Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
EXPERIMENTAL: Sitaxsentan plus Rifampin
Drug: Sitaxsentan
Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)
Drug: Rifampin
Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
Time Frame: 24 hours
24 hours
Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan 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

December 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

January 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

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1321060

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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