NCT06323655

Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Three-way Crossover Study in Healthy Subjects to Evaluate the Next-day Residual Effects of 20 mg Tasimelteon

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tasimelteon	oral capsule
DRUG	Active Control Placebo	oral capsule
DRUG	Tasimelteon Placebo	oral capsule
DRUG	Active Control	oral capsule

Timeline

• Start date: 2018-07-19
• Primary completion: 2018-08-28
• Completion: 2018-08-28
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study