Single-center, double-blind, randomized, placebo-controlled, single-ascending dose and food interaction study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy male subjects
Completed
- Conditions
- Acute inflammation1004795410027665
- Registration Number
- NL-OMON35247
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
Healthy Caucasian male subject
Exclusion Criteria
Clinically significant abnormalities at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• to evaluate the safety and tolerability of ascending single oral doses of the<br /><br>test compound ACT-389949 (test medication) in healthy male subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>• to study how the test compound ACT-389949 is absorbed, broken-down and<br /><br>excreted by the body and how it affects the functioning of the body<br /><br><br /><br>• to investigate whether increasing the dose of ACT-389949 with a certain<br /><br>proportion results in an increase in the effect of ACT-389949 with that same<br /><br>proportion<br /><br><br /><br>• to study the impact of food on how a single dose of ACT-389949 is absorbed,<br /><br>broken-down and excreted by the body</p><br>