Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- Area under the curve
研究概览
简要总结
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.
详细描述
This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.
Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:
Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of providing informed consent.
- •Male or female aged ≥ 18 years to < 65 years
- •Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
- •Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
- •Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
- •If a sexually active female of childbearing potential, using a medically accepted contraceptive method.
排除标准
- •Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
- •If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
- •History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
- •Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
- •In the investigator's opinion, at imminent risk of committing self-harm
- •Use of depot antipsychotics within the last three months
- •Receipt of any investigational drugs within the last three months
- •Current participation in any other clinical trial
研究组 & 干预措施
Risperidone ISM 50mg
Three different single doses will be evaluated
干预措施: Risperidone ISM 50 mg (Drug)
Risperidone ISM 75mg
Three different single doses will be evaluated
干预措施: Risperidone ISM 75 mg (Drug)
Risperidone ISM 100mg
Three different single doses will be evaluated
干预措施: Risperidone ISM 100 mg (Drug)
结局指标
主要结局
Area under the curve
时间窗: Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame
次要结局
未报告次要终点