NCT07185815招募中1 期
A Prospective, Dose Escalating, Open Label, Multi-center, Phase I/IIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 9
- 主要终点
- Safety, rate of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral Cariprazine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet DSM-5-TR diagnostic criteria for schizophrenia, bipolar I disorder or major depressive disorder (this inclusion criterion relates to cohorts 1 and 2 only).
- •Clinically stable subjects (with no evidence of deterioration and on a stable dose of oral antipsychotic or antidepressant medication(s) other than Cariprazine for at least 4 weeks, prior to screening), receiving antipsychotic/s or antidepressant/s other than oral Cariprazine and eligible for treatment with Cariprazine 3 mg/day, with CGI-S score of 1-
- •Men and women aged 18-64 years (inclusive).
- •Body mass index (BMI) 18.5-
- •Able to sign an informed consent form.
- •Adult subjects with a current diagnosis of schizophrenia, who meet DSM-5-TR diagnostic criteria for schizophrenia, naïve to or treated with antipsychotics (this inclusion criterion relates to cohort 3 only).
排除标准
- •Subjects with schizophrenia with PANSS item scores of > 4 on any of the following: P4 Excitement/Hyperactivity; P6 Suspiciousness/persecution; P7 Hostility; G8 Uncooperativeness; G14 Poor impulse control.
- •Subjects with schizoaffective disorder, delirium, dementia, amnestic, or other cognitive disorders or severe personality disorders.
- •Use of an investigational drug, and/or participation in clinical studies with an investigational product within 3 months prior to screening.
- •History or current cardiovascular or cerebrovascular disease.
- •History of seizures or conditions that lower the seizure threshold.
- •Use of concomitant administration of strong or moderate CYP3A4 inhibitors.
- •Use of concomitant medication of strong or moderate CYP3A4 inducers is contraindicated.
- •Subjects with Suicidal Thoughts and Behaviors or has a history of suicidal ideation in the past year, or made a suicide attempt in the past 5 years.
- •Subjects with a history of orthostatic hypotension and/or syncope.
- •Subjects clinically stable on any dose of oral Cariprazine or add-on treatment (cohorts 1-2 only).
- •Subjects with CGI-S score of 5-
- •Subjects previously treated with partial D2 agonists, aripiprazole and brexipiprazole, and suffered from clinically relevant akathisia.
- •For cohort 3 only: Subjects treated with oral Clozapine.
研究组 & 干预措施
Cohort 3
Experimental
干预措施: Cariprazine Depot MTD (Drug)
Cohort 3
Experimental
干预措施: Oral Cariprazine 3 mg/day (Drug)
Cohort 1
Experimental
干预措施: Cariprazine Depot (Drug)
Cohort 2
Experimental
干预措施: Cariprazine Depot (Drug)
结局指标
主要结局
Safety, rate of adverse events (AEs)
时间窗: Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort
Plasma concentration of cariprazine and its active metabolites (DCAR, DDCAR)
时间窗: Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort
次要结局
- Tolerability - Incidence and severity of injection site reactions(Through study completion, up to 22 weeks for each subject in the first 2 cohorts and up to 24 weeks for each subject in the 3rd cohort)
- Efficacy - Cohort 3: Positive and Negative Symptom Score (PANSS)(Through study completion, up to 24 weeks for each subject in the 3rd cohort)
- Efficacy - Cohort 3: Clinical Global Impression Scale (CGI)(Through study completion, up to 24 weeks for each subject in the 3rd cohort)
研究者
研究点 (9)
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