NCT06323655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

October 18, 2019

Last Update Submit

March 19, 2024

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (3)

Tasimelteon

EXPERIMENTAL

single dose

Drug: TasimelteonDrug: Active Control Placebo

Placebo

PLACEBO COMPARATOR

single dose

Drug: Active Control PlaceboDrug: Tasimelteon Placebo

Active Control

ACTIVE COMPARATOR

single dose

Drug: Tasimelteon PlaceboDrug: Active Control

Interventions

TasimelteonDRUG

oral capsule

Tasimelteon
Active Control PlaceboDRUG

oral capsule

PlaceboTasimelteon
Tasimelteon PlaceboDRUG

oral capsule

Active ControlPlacebo
Active ControlDRUG

oral capsule

Active Control

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

Laval, Quebec, Canada

Location

MeSH Terms

Interventions

tasimelteon

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

March 21, 2024

Study Start

July 19, 2018

Primary Completion

August 28, 2018

Study Completion

August 28, 2018

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

CA(1)