A Phase 1b, Multicenter, Open-label, Multiple Ascending Dose Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects (4 to 12 Years, Inclusive) With Attention-deficit Hyperactivity Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country50 target enrollmentMarch 9, 2021

ConditionsAttention-deficit Hyperactivity Disorder

InterventionsCentanafadine

DrugsCentanafadine

Overview

Phase: Phase 1
Intervention: Centanafadine
Conditions: Attention-deficit Hyperactivity Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 50
Locations: 1
Primary Endpoint: Maximal peak plasma concentration (Cmax)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of ADHD.

Registry

clinicaltrials.gov

Start Date

March 9, 2021

End Date

April 26, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
•A diagnosis of any ADHD subtype based on Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

Exclusion Criteria

•Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms.
•Subjects with developmental disorders, such as autism spectrum disorder.
•Subjects with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient \< 70, or clinical evidence, or a social or school history that is suggestive of intellectual disability.
•Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/ AIDS, or chronic hepatitis B or C.
•Subjects who have history of clinically significant tachycardia or hypertension.