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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tasimelteon; Drug: Active Control; Drug: Active Control Placebo; Drug: Tasimelteon Placebo

• Registration Number: NCT06323655
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-19
• Primary Completion: 2018-08-28
• Study Completion: 2018-08-28
• Study First Submitted: 2019-10-18
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Ability to provide written consent;
• Healthy subjects with no medical, psychiatric, or current sleep disorders;
• Men and women ages 21 - 55, inclusive;
• Possession of a valid driver's license ≥ 3 years with reported annual mileage ≥ 3,000 km.

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Exclusion Criteria

• Pregnancy or recent pregnancy;
• Subjects who are unable to read or speak English or French.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Control	Active Control	single dose
Tasimelteon	Tasimelteon	single dose
Tasimelteon	Active Control Placebo	single dose
Placebo	Active Control Placebo	single dose
Placebo	Tasimelteon Placebo	single dose
Active Control	Tasimelteon Placebo	single dose

Primary Outcome Measures

Name	Time	Method
Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP)	Day 1 of Treatment Period 1, Treatment Period 2, and Treatment Period 3 (each Period is 1 day, separated by washout)

Trial Locations

Locations (1)

Vanda Investigational Site; 🇨🇦 Laval, Quebec, Canada