Overview

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

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Criteria
Key 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.