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

NCT04081363 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 405-201-00037
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Swallowed Capsules Cohort

EXPERIMENTAL

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

Sprinkled Onto Applesauce Cohort

EXPERIMENTAL

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

Interventions

Centanafadine DRUG

Extended-release and immediate-release capsules.

Also known as: EB-1020

Sprinkled Onto Applesauce Cohort; Swallowed Capsules Cohort

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

For additional information regarding sites, contact 844-687-8522

New York, New York, 14618, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All the participants received only centanafadine but divided into 2 arm groups based on administration (as capsules or drug sprinkled onto applesauce).

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: October 7, 2019
• Primary Completion: December 21, 2019
• Study Completion: December 21, 2019
• Last Updated: January 13, 2023
• Results First Posted: January 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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

Locations

US (1)