Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
NCT02776215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2024-03-21
Summary
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
Conditions
- Circadian Rhythm Sleep Disorders
- Non-24 Hour Sleep-Wake Disorder
- Autism Spectrum Disorder
- Smith-Magenis Syndrome
Interventions
- DRUG
-
tasimelteon
Melatonin receptor agonist
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Vanda Pharmaceuticals · Sponsor GmbH
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-04
- Primary Completion
- 2017-12-20
- Completion
- 2017-12-20
Countries
- United States
Study Locations
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