NL-OMON45870
Completed
Not Applicable
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. - CS0296 (ID-054-106)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Idorsia Pharmaceuticals Ltd
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.
Outcomes
Primary Outcomes
Not specified
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