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

March 19, 2024 updated by: Vanda Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Laval, Quebec, Canada
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
single dose
Drug: Active Control Placebo
oral capsule
Drug: Tasimelteon Placebo
oral capsule
Experimental: Tasimelteon
single dose
Drug: Tasimelteon
oral capsule
Drug: Active Control Placebo
oral capsule
Active Comparator: Active Control
single dose
Drug: Tasimelteon Placebo
oral capsule
Drug: Active Control
oral capsule

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2018

Primary Completion (Actual)

August 28, 2018

Study Completion (Actual)

August 28, 2018

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VP-VEC-162-1201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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