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Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol

NCT01578057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-02-17

No results posted yet for this study

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.

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578057 on ClinicalTrials.gov