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

June 1, 2022 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hollywood, Florida, United States, 33024
        • For additional information regarding sites, contact 844-687-8522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent.
  • Subjects must weight ≥ 13 kg.
  • Subjects with 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).
  • Subject is judged by the investigator to be clinically stable, and has not had any psychiatric hospitalizations within the past 12 weeks.
  • Subjects and their caregivers must be able and willing to utilize the AiCure Platform for each daily dose.

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 psychiatric or general medical condition(s) or direct effect of a substance.
  • Subjects with developmental disorders, such as Autism Spectrum Disorder.
  • Subjects with a history of at least mild intellectual disability as determined by IQ < 70, clinical evidence, or a social or school history that is suggestive of intellectual disability.
  • Subjects with hypothyroidism or hyperthyroidism (unless condition has been stabilized with medications for at least 90 days prior to first dose of IMP) or an abnormal result for free T4 at screening.
  • 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 with insulin dependent diabetes mellitus (i.e. any subjects using insulin)
  • Subjects with epilepsy, Tourette's Disorder, or a history of seizures or a history of severe head trauma or cerebrovascular disease.
  • Any major surgery within 30 days prior to the first dose of IMP.
  • Any history of significant bleeding or hemorrhagic tendencies.
  • Blood transfusions within 30 days prior to the first dose of IMP.
  • Subjects who have supine or standing diastolic blood pressure, after resting for at least 5 minutes, > 80 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 who have had any previous exposure to centanafadine.
  • Subjects with a history of true allergic response to a medication or a history of dermatologic adverse reactions or anaphylaxis secondary drug exposure.
  • Subjects with a history of allergic reaction or known or suspected sensitivity to any substance that is contained in the IMP formulation.
  • Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for collecting blood samples.
  • Consumption of alcohol and/or food and beverages containing methylxanthines, foods known to affect CYP1A2 (e.g. charbroiled or pan-fried meats and cruciferous vegetables) within 72 hours prior to dosing.
  • Relative of the trial site employees cannot participate in the trial.
  • Siblings, other family members, and those having the same place of residence as the subject are also excluded from the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 (9-12 y)
Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days
Drug: Centanafadine
Extended release capsule
Experimental: Cohort 2 (9-12 y)
Centanafadine extended release capsule; 200 mg adult equivalent; twice daily for 14 days
Drug: Centanafadine
Extended release capsule
Experimental: Cohort 3 (9-12 y)
Centanafadine extended release capsule; 400 mg adult equivalent; twice daily for 14 days
Drug: Centanafadine
Extended release capsule
Experimental: Cohort 4 (6-8 y)
Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days
Drug: Centanafadine
Extended release capsule
Experimental: Cohort 5 (4-5 y)
Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days
Drug: Centanafadine
Extended release capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximal peak plasma concentration (Cmax)
Time Frame: 24 hours
24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Time Frame: 24 hours
24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 405-201-00010

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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