NCT03292848

Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders

A Phase 1, Single-dose, Sequential Cohort, Nonrandomized Crossover Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Oral Brexpiprazole in Children (6 to< 13 Years Old) With Central Nervous System Disorders

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.

Detailed description

A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders who are receiving antipsychotic treatment for their medical condition.

Conditions

• ADHD
• Autism
• Bipolar I Disorder
• Conduct Disorder
• Oppositional Defiant Disorder

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Tablet

Timeline

• Start date: 2017-10-10
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2017-09-26
• Last updated: 2018-06-12

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study