Attention Deficit Hyperactivity DisorderPhase 1NCT04398225
A Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine in Pediatric Subjects With Attention-deficit/Hyperactivity Disorder
A Phase 1 study testing Centanafadine in people with Attention Deficit Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Centanafadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 1 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding sites, contact 844-687-8522
Hollywood, Florida, 33024
About this study
Official title: 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Centanafadine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentanafadineDrug
Extended release capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (9-12 y) | Experimental | Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days Receives: Drug: Centanafadine |
| Cohort 2 (9-12 y) | Experimental | Centanafadine extended release capsule; 200 mg adult equivalent; twice daily for 14 days Receives: Drug: Centanafadine |
| Cohort 3 (9-12 y) | Experimental | Centanafadine extended release capsule; 400 mg adult equivalent; twice daily for 14 days Receives: Drug: Centanafadine |
| Cohort 4 (6-8 y) | Experimental | Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days Receives: Drug: Centanafadine |
| Cohort 5 (4-5 y) | Experimental | Centanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days Receives: Drug: Centanafadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal peak plasma concentration (Cmax)
Measured: 24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Measured: 24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start11 Jun 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398225
- Sponsor's protocol ID
- 405-201-00010
- Status last verified
- May 2022
- First submitted
- 18 May 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04398225
- Acronym / sponsor ID
- 405-201-00010
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate the pharmacokinetics, safety, and tolerability of centanafadine in pediatric subjects with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (9-12 y) | Experimental | Drug: CentanafadineCentanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days |
| Cohort 2 (9-12 y) | Experimental | Drug: CentanafadineCentanafadine extended release capsule; 200 mg adult equivalent; twice daily for 14 days |
| Cohort 3 (9-12 y) | Experimental | Drug: CentanafadineCentanafadine extended release capsule; 400 mg adult equivalent; twice daily for 14 days |
| Cohort 4 (6-8 y) | Experimental | Drug: CentanafadineCentanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days |
| Cohort 5 (4-5 y) | Experimental | Drug: CentanafadineCentanafadine extended release capsule; 100 mg adult equivalent; twice daily for 14 days |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CentanafadineExtended release capsule | Drug | Cohort 1 (9-12 y), Cohort 2 (9-12 y), Cohort 3 (9-12 y), Cohort 4 (6-8 y), Cohort 5 (4-5 y) |
Primary outcome
Maximal peak plasma concentration (Cmax)
Time frame: 24 hours
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) on day 14
Time frame: 24 hours
Apparent clearance and apparent volume of distribution of centanafadine on Day 14
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Centanafadine in people with Attention Deficit Hyperactivity Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal peak plasma concentration (Cmax) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.