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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tasimelteon Placebo; Drug: Active Control; Drug: Active Control Placebo; Drug: Tasimelteon

Study type: Interventional

Funder types: Industry

Identifiers

NCT06323655

VP-VEC-162-1201

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups, including a placebo group

Tasimelteon

Experimental group

Description:

single dose

Treatment:

Drug: Active Control Placebo

Drug: Tasimelteon

Placebo

Placebo Comparator group

Description:

single dose

Treatment:

Drug: Tasimelteon Placebo

Drug: Active Control Placebo

Active Control

Active Comparator group

Description:

single dose

Treatment:

Drug: Tasimelteon Placebo

Drug: Active Control