Completed PHASE1 INTERVENTIONAL 4-arm 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

Sponsor: Vanda Pharmaceuticals

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

Interventions Ethanol Placebo ethanol Placebo tasimelteon tasimelteon

Updated 6 times since 2017 Last updated: Feb 14, 2014 Started: Apr 30, 2012 Primary completion: Jun 30, 2012 Completion: Jun 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol and is currently completed. Vanda Pharmaceuticals leads this study, which shows 6 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Apr 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Vanda Pharmaceuticals

Data source: Vanda Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Toronto, Canada