Status:
COMPLETED
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
9-12 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04081363
Start Date
October 7 2019
End Date
December 21 2019
Last Update
January 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 14618