A prospective, dose escalating, open label, multi-center, Phase I/IIa study to to evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in in subjects eligible for treatment with oral Cariprazine.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
This is a Phase I/IIa study, aimed to assess the safety, tolerability and PK of Cariprazine Depot escalating doses of 22 mg and 44 mg as a single dose.
Following the determination of the Maximum Tolerated Dose (MTD), based on the safety data from cohorts 1 and 2, Cariprazine Depot dose for cohort 3 will be determined. The selection of the dose for cohort 3 will depend on both the MTD and the PK profile. Twenty four subjects diagnosed with schizophrenia will be enrolled in the 3rd cohort.
In addition, it is aimed to assess the safety, tolerability, PK and efficacy of the MTD of Cariprazine Depot, administered once every 4 weeks in a 12-week treatment period.
Primary Endpoints:
• Safety, rate of adverse events (AEs)
• PK Profile
Secondary Endpoints:
• Tolerability
• Efficacy (cohort 3 only)
Safety and tolerability outcome measures will be evaluated:
Safety:
• Adverse events.
• Vital signs.
• ECG findings.
• Laboratory parameters, etc.
Tolerability:
Incidence and severity of injection site reactions.
Efficacy:
Positive and Negative Symptom Score (PANSS), 30-item scale - a validated, multi-item inventory, composed of three subscales to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression, scores range from 30 to 210, where higher values represent a worse outcome.
Clinical Global Impression-Severity scale, a validated clinician-related scale from 1 to 7, measures the patient’s current illness state and overall clinical state, where higher values represent a worse outcome. The Clinical Global Impression-Severity (CGI-S) and improvement (CGI-I) scales score will be summarized by treatment group and by visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria: 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 0-
- •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
- •Key Exclusion Criteria: Subjects with schizophrenia with PANSS item scores of greater than 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.
研究者
Dr Sandeep Singh
CBCC Global Research