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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- PK Parameter: Time to Maximum Plasma Concentration (Tmax) of Centanafadine
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Swallowed Capsules Cohort
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.
干预措施: Centanafadine (Drug)
Sprinkled Onto Applesauce Cohort
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.
干预措施: Centanafadine (Drug)
结局指标
主要结局
PK Parameter: Time to Maximum Plasma Concentration (Tmax) of Centanafadine
时间窗: 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
时间窗: 0 to 12 hours post dose on Day 1
Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Centanafadine
时间窗: 1, 2, 3, 4, 6, 8, 10,12 hours post dose on Day 1 and 22-26 hours post dose on Day 2
次要结局
未报告次要终点