NCT01578057

Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol

A Randomized, Double-mask, Four-period Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: Female
• Age: 19 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

Alcohol is a drug that gets absorbed into the bloodstream quickly. The blood carries the alcohol to the brain where it slows down the messages in the brain (alcohol is a depressant). Alcohol affects a person's memory, behaviour, concentration, alertness (your thought process is slower), and coordination (your movements become clumsy). The intended effect of tasimelteon is to cause sleepiness. Sleepiness may result in similar effects on memory, concentration, alertness, and coordination as alcohol. There is the possibility taking tasimelteon and alcohol together can make these effects stronger or worse.

Conditions

• Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol

Interventions

Type	Name	Description
DRUG	tasimelteon	20mg, once
DRUG	Ethanol	0.6 g/kg ethanol (women) or 0.7 g/kg ethanol (men) in a total volume of 300 mL as a light cranberry juice cocktail, (consumed within 15 minutes).
OTHER	Placebo tasimelteon	once
DRUG	Placebo ethanol	A total volume of 300 mL as a light cranberry cocktail (consumed within 15 minutes) with about 1 mL of supernatant of ethanol in the top

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-04-16
• Last updated: 2014-02-17

Locations

1 site across 1 country: Canada