Drug Interaction Between Ritonavir And Sitaxsentan
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
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2011
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMarch 5, 2015
March 1, 2015
1 month
December 1, 2010
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
24 hours
The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
24 hours
The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
24 hours
The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
24 hours
Study Arms (3)
Treatment A
ACTIVE COMPARATORTreatment B
ACTIVE COMPARATORTreatment C
EXPERIMENTALInterventions
Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 2, 2010
Study Start
January 1, 2011
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
March 5, 2015
Record last verified: 2015-03