NCT01578057 - Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions

Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol

Interventions

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

Trial Locations (1)

INC Research Toronto, Inc., Toronto