A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/12/2018 |
| Start Date: | July 1, 2016 |
| End Date: | October 1, 2016 |
A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects
The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of
midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577
when administered alone and in combination with midazolam.
midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577
when administered alone and in combination with midazolam.
Inclusion Criteria:
- Signed informed consent in the local language prior to any study-mandated procedure
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
- Healthy on the basis of medical history, physical examination, cardiovascular
assessments and serology and laboratory tests
Exclusion Criteria:
- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol
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