A single-center, randomized, double-blind, two-period cross-over study to investigate the effect of rifampicin on the pharmacokinetics of clazosentan in healthy male subjects.
Completed
- Conditions
- 10002363cerebral vasospasm (cerebral hemorrhage)
- Registration Number
- NL-OMON45870
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
Healthy male subjects aged between 18 and 65 years (inclusive) with a Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening. ;Further inclusion criteria can be found in the protocol section 3.2.2.
Exclusion Criteria
1. Previous exposure to clazosentan.
2. Previous exposure to rifampicin within 3 months prior to Screening.
3. Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients. ;Further exclusion criteria can be found in the protocol section 3.2.3.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The pharmacokinetic parameters.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The safety endpoint parameters are frequency and severity of adverse events,<br /><br>vital signs, electrocardiography (ECG),<br /><br>safety laboratory tests and urinalysis.</p><br>