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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT01251835 |
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Date of registration:
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01/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan
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Scientific title:
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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 |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01251835 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Rifampin
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Drug: Sitaxsentan
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Drug: Sitaxsentan alone
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Primary Outcome(s)
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Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
[Time Frame: 24 hours]
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Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.
[Time Frame: 24 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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