Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- 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
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.
Exclusion Criteria
- Pregnancy or recent pregnancy;
- Subjects who are unable to read or speak English or French.
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)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of tasimelteon in modulating circadian rhythm through MT1 and MT2 receptors in healthy volunteers?
How does the pharmacokinetic profile of tasimelteon compare to active controls in mitigating next-day residual effects in phase 1 trials?
What biomarkers correlate with residual sedation effects in healthy subjects receiving melatonin receptor agonists like tasimelteon?
What adverse event management strategies are employed in phase 1 trials of melatonin receptor agonists such as tasimelteon?
How do tasimelteon's next-day residual effects compare to other chronotherapeutic agents in sleep disorder treatment development?
Trial Locations
- Locations (1)
Vanda Investigational Site
🇨🇦Laval, Quebec, Canada
Vanda Investigational Site🇨🇦Laval, Quebec, Canada