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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04786730

Enrollment

Registered

2021-03-08

Start date

2021-03-09

Completion date

2023-04-26

Last updated

2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-deficit Hyperactivity Disorder

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.

Interventions

DRUGCentanafadine

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026