drugset / Trial / NCT01578057
Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
RandomizedCrossoverDouble-blindBasic science
Summary
The purpose of this research study is to understand if there is any difference in the effects of tasimelteon when it is taken alone or in combination with alcohol. This research study is also being done to understand if there is any difference in the amount of tasimelteon (and its breakdown products) or alcohol in the blood when taken alone or together. Finally, the study will also look at the safety and tolerability (how acceptable it is) of tasimelteon.
Timeline
- Start
- 2012-04
- Primary completion
- 2012-06
- Completion
- 2012-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 0.6 g/kg | Oral |
| Subject | Alcohol | Other / unclassified | 0.7 g/kg | Oral |
| Subject | tasimelteon | Small molecule | 20 mg | — |
Indications
No indication recorded.