A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder

Phase 1

Completed

• Conditions: Attention-deficit Hyperactivity Disorder
• Interventions: Drug: Centanafadine

• Registration Number: NCT04786730
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Study Start: 2021-03-09
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Key

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label centanafadine	Centanafadine	There will be multiple cohorts dosed with open-label centanafadine.

Primary Outcome Measures

Name	Time	Method
Maximal peak plasma concentration (Cmax)	24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14	24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14	24 hours

Trial Locations

Locations (1)

For additional information regarding sites, contact 844-687-8522; 🇺🇸 San Antonio, Texas, United States