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

Attention-deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786730
• Other study ID #: 405-201-00046
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: July 2023
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	Decatur	Georgia
United States	For additional information regarding sites, contact 844-687-8522	Las Vegas	Nevada
United States	For additional information regarding sites, contact 844-687-8522	Little Rock	Arkansas
United States	For additional information regarding sites, contact 844-687-8522	Oklahoma City	Oklahoma
United States	For additional information regarding sites, contact 844-687-8522	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal peak plasma concentration (Cmax)		24 hours
Primary	Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14		24 hours
Primary	Apparent clearance and apparent volume of distribution of centanafadine on Day 14		24 hours