Pulmonary Arterial Hypertension
Conditions
Keywords
Sitaxsentan, Rifampin, Drug Interaction, Pharmacokinetics
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.
Interventions
DRUGSitaxsentan alone
Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
DRUGSitaxsentan
Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)
DRUGRifampin
Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone. | 24 hours |
| Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone. | 24 hours |
Outcome results
None listed