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

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04081363
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

With the 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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: Centanafadine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 7, 2019
• Actual Primary Completion Date: Dec 21, 2019
• Actual Study Completion Date: Dec 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Single oral dose (50 mg) capsule of extended-release centanafadine	Drug: Centanafadine; Extended-release capsule; Other Names: EB-1020

Outcome Measures

Primary Outcome Measures

1. PK parameter maximum drug concentration (Cmax) of centanafadine [Up to 12 hours]

2. PK parameter time of Cmax (tmax) of centanafadine [Up to 12 hours]

3. PK parameter area under concentration-time curve from time 0 to 12 hours (AUC0-12h) of centanafadine [Up to 12 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent obtained from a legally acceptable representative and assent obtained from the subject prior to the initiation of any trial-related procedures.

• Male or female subjects 9 to 12 years of age, inclusive, at the time of informed consent.

• Subjects with documented history of ADHD and confirmation of an ADHD prescription medication.

• Subject is judged by the investigator to be clinically stable and has not had any psychiatric hospitalizations within the past 12 weeks.

Exclusion Criteria:

• Subjects 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.

• Subjects 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 C-SSRS.

• Subjects 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.

• Subjects with hypothyroidism or hyperthyroidism or an abnormal result for free thyroxine (T4) at screening.

• Subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.

• Subjects with insulin-dependent diabetes mellitus.

• Subjects 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 IMP.

• Any history of significant bleeding or hemorrhagic tendencies.

• Blood transfusion within 30 days prior to dosing with IMP.

• Subjects 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.

• Subjects who have a supine or standing diastolic blood pressure, after resting for at least 5 minutes ≥ 95 mmHg.

• Subjects 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.

• Subjects with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary to drug exposure.

• Subjects 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding sites, contact 844-687-8522	New York	New York	United States	14618

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT04081363
• Other Study ID Numbers: 405-201-00037
• First Posted: Sep 9, 2019
• Last Update Posted: Nov 25, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: ADHD
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Nov 25, 2020