Back to resultsEffect Of Rifampin On Pharmacokinetics Of Sitaxsentan
Primary Purpose
Pulmonary Arterial Hypertension
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sitaxsentan alone
Sitaxsentan
Rifampin
Sponsored by
About this trial
This is an interventional basic science trial for Pulmonary Arterial Hypertension focused on measuring Sitaxsentan, Rifampin, Drug Interaction, Pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sitaxsentan
Sitaxsentan plus Rifampin
Arm Description
Outcomes
Primary Outcome Measures
Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01251835
Brief Title
Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Sitaxsentan, Rifampin, Drug Interaction, Pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitaxsentan
Arm Type
Active Comparator
Arm Title
Sitaxsentan plus Rifampin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sitaxsentan alone
Intervention Description
Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
Intervention Type
Drug
Intervention Name(s)
Sitaxsentan
Intervention Description
Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)
Primary Outcome Measure Information:
Title
Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
Time Frame
24 hours
Title
Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321060&StudyName=Effect%20Of%20Rifampin%20On%20Pharmacokinetics%20Of%20Sitaxsentan
Description
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Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan
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