Phase I study to assess the pharmacokinetics and pharmacodynamics of macitentan in Korean healthy male subjects
Not Applicable
Completed
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0000326
- Lead Sponsor
- Actelion Pharmaceuticals Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
1. Healthy Korean adult males
2. Aged 20 to 50 years, inclusive, at screening
3. Healthy on the basis of medical history and the assessments performed at screening
Exclusion Criteria
1. History of clinically relevant hypersensitivity or serious adverse reactions to any drug
2. Abnormal values that suggest a clinically significant underlying disease or subject with the following lab abnormalities:
1)Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.25 × the upper limits of normal
2)Total bilirubin > 1.5 × the upper limits of normal
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;tmax;Ctrough;AUC0-24;t½;Accumulation index (R)
- Secondary Outcome Measures
Name Time Method