NCT04786730|CompletedPhase 1FDA Drug

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

Otsuka Pharmaceutical Development & Commercialization, Inc.ClinicalTrials.gov

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1 other identifier

405-201-00046

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2021

StartedMar 2021

CompletionApr 2023

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Mar 2021

Typical duration for phase_1

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

February 25, 2021

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed

1 day until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed

Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

February 25, 2021

Last Update Submit

July 11, 2023

Conditions

Attention-deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

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

Study Arms (1)

Open-label centanafadine

EXPERIMENTAL

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

Drug: Centanafadine

Interventions

CentanafadineDRUG

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).

Open-label centanafadine

Eligibility Criteria

Age4 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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).

You may not qualify if:

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.

Contact the study team to confirm eligibility.