Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 7:41 PM
Study NCT ID:
NCT01578057
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
Sponsor:
Vanda Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-mask, Four-period Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: