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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06323655
Enrollment
48
Registered
2024-03-21
Start date
2018-07-19
Completion date
2018-08-28
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGTasimelteon

oral capsule

DRUGActive Control Placebo

oral capsule

DRUGTasimelteon Placebo

oral capsule

DRUGActive Control

oral capsule

Sponsors

Vanda Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026