drugset / Trial / NCT02919319
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
RandomizedParallel-groupTriple-blindOther
Summary
The main objectives of this first-into-man study were to investigate the safety, tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults. Pharmacodynamic effects (through a battery of Central Nervous System tests) were also assessed.
Timeline
- Start
- 2015-02-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daridorexant | Small molecule | 2.02 ug | Oral |
| Subject | Daridorexant | Small molecule | 5 mg | Oral |
| Subject | Daridorexant | Small molecule | 25 mg | Oral |
| Subject | Daridorexant | Small molecule | 50 mg | Oral |
| Subject | Daridorexant | Small molecule | 100 mg | Oral |
| Subject | Daridorexant | Small molecule | 200 mg | Oral |
Indications
No indication recorded.