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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-09

Study Completion Date

2023-04-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention-deficit Hyperactivity Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label centanafadine

There will be multiple cohorts dosed with open-label centanafadine.

Group Type EXPERIMENTAL

Centanafadine

Intervention Type DRUG

Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohorts (Cohorts 1 and 6), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).

Interventions

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Centanafadine

Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohorts (Cohorts 1 and 6), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No