Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)

A Pilot Phase 2a, Multicenter, Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules After Oral Administration in Pediatric Subjects (9 to 12 Years, Inclusive) With Attention-deficit Hyperactivity Disorder

With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal tract. The information in this trial will support pediatric dose selection in future trials.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Centanafadine

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 14618
      • For additional information regarding sites, contact 844-687-8522

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent obtained from a legally acceptable representative and assent obtained from the participant prior to the initiation of any trial-related procedures.
• Male or female participants 9 to 12 years of age, inclusive, at the time of informed consent.
• Participants with documented history of ADHD and confirmation of an ADHD prescription medication.
• Participant is judged by the investigator to be clinically stable and has not had any psychiatric hospitalizations within the past 12 weeks.

Exclusion Criteria:

• Participants with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient (IQ) < 70, or clinical evidence, or a social or school history that is suggestive of an intellectual disability.

• Participants who have any of the following:

  • Significant risk of committing suicide based on history
  • Current suicidal behavior
  • Imminent risk of injury to self
  • Active suicidal ideation
  • Any lifetime history of suicidal behavior detected by the "Baseline/Screening" version of the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Participants with a lifetime history of a substance use disorder (as determined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM-5] criteria), or current substance misuse including alcohol and benzodiazepines, but excluding caffeine and nicotine.
• Participants with hypothyroidism or hyperthyroidism or an abnormal result for free thyroxine (T4) at screening.
• Participants who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.
• Participants with insulin-dependent diabetes mellitus.
• Participants with epilepsy or a history of seizures or a history of severe head trauma or cerebrovascular disease.
• Any major surgery within 30 days prior to dosing with the investigational medicinal product (IMP).
• Any history of significant bleeding or hemorrhagic tendencies.
• Blood transfusion within 30 days prior to dosing with IMP.
• Participants with a positive drug screen for cocaine, marijuana (even if by prescription), or other illicit drugs, or alcohol, are excluded and may not be retested or rescreened.
• Participants who have a supine or standing diastolic blood pressure, after resting for at least 5 minutes ≥ 95 mmHg.
• Participants who participated in a clinical trial and were exposed to IMP within the last 30 days prior to screening or who participated in more than 2 interventional clinical trials within the past year.
• Participants with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary to drug exposure.
• Participants who do not tolerate venipuncture or have poor venous access that would cause difficulty when collecting blood samples.
• Relatives of the trial site employees cannot participate in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Swallowed Capsules Cohort; Participants swallowed two capsules of centanafadine (one containing a 50-milligram [mg] dose as extended release beads and other containing a 5-mg dose as immediate-release [IR] beads), total dose of 55 mg, orally in the morning of Day 1 following a minimum 8-hour fast.	Drug: Centanafadine; Extended-release and immediate-release capsules.; Other Names: EB-1020
Experimental: Sprinkled Onto Applesauce Cohort; Participants were administered centanafadine 55 mg, contents of 2 capsules (one containing a 50-mg dose as beads and other containing a 5-mg dose as IR beads) sprinkled on a tablespoon of applesauce, orally in the morning of Day 1 following a minimum 8-hour fast.	Drug: Centanafadine; Extended-release and immediate-release capsules.; Other Names: EB-1020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Centanafadine	1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2
PK Parameter: Time to Maximum Plasma Concentration (Tmax) of Centanafadine	1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2
PK Parameter: Area Under Concentration-time Curve From Time 0 to 12 Hours Postdose (AUC0-12h) of Centanafadine	0 to 12 hours post dose on Day 1

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): December 21, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 405-201-00037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No