Back to resultsDrug Interaction Between Ritonavir And Sitaxsentan
Primary Purpose
Pulmonary Arterial Hypertension
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sitaxentan
Ritonavir
Sitaxsentan
Ritonavir
Sponsored by
About this trial
This is an interventional basic science trial for Pulmonary Arterial Hypertension focused on measuring Sitaxentan, ritonavir, drug interaction, pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Arm Description
Outcomes
Primary Outcome Measures
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01251848
Brief Title
Drug Interaction Between Ritonavir And Sitaxsentan
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Sitaxentan, ritonavir, 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
Treatment A
Arm Type
Active Comparator
Arm Title
Treatment B
Arm Type
Active Comparator
Arm Title
Treatment C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sitaxentan
Intervention Description
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
Intervention Type
Drug
Intervention Name(s)
Sitaxsentan
Intervention Description
Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days
Primary Outcome Measure Information:
Title
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Time Frame
24 hours
Title
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
Time Frame
24 hours
Title
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
Time Frame
24 hours
Title
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir 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 (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.
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=B1321061&StudyName=Drug%20Interaction%20Between%20Ritonavir%20And%20Sitaxsentan%20
Description
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Learn more about this trial
Drug Interaction Between Ritonavir And Sitaxsentan
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