NCT06319170已完成1 期
A Multi-center, Open-label, Randomized, Parallel-group Trial to Characterize the Pharmacokinetics of Three SC Olanzapine Extended-release Formulations With Different Release Rates Following Single Administration in Participants With Schizophrenia or Schizoaffective Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 5
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
研究概览
简要总结
The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.
A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine.
Another secondary objective is to characterize the pharmacokinetics of ZYPREXA.
The planned duration of the study for each participant is 19 weeks.
详细描述
All participants received immediate-release ZYPREXA and then were randomized into 1 of 3 extended-release olanzapine formulations.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight >50 kg and body mass index (BMI) within the range 18.5 to 38.0 kg/m2, inclusive, at the time of screening
- •Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the trial until completion of the end of treatment or early termination (ET) visit (ie, nonsmoking participants must agree not to start smoking and participants who smoke will be excluded if they plan to discontinue smoking during the trial
- •Agree to the inpatient periods required during the trial period
- •Have a current confirmed diagnosis of schizophrenia or schizoaffective disorder according to an evaluation by the Investigator, using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association 2013a)
- •Have no ongoing or expected significant life events (eg, pending loss of housing, marital status change, long travel abroad, surgery) that could affect trial outcomes throughout the period of trial participation
- •Women may be included only if they have a negative serum beta human chorionic gonadotropin (HCG) test result at screening; they are surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal
- •Men must be sterile; or if they are potentially of reproductive competence and have sexual relationship with female partners of childbearing potential, they must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 70 days after the last dose administration
- •NOTE- Additional criteria apply, please contact the investigator for more information
排除标准
- •Presence or have a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal system, or presence or history of clinically significant immunological, endocrine, or metabolic diseases, neurological or psychiatric disorder(s) (other than schizophrenia)
- •History or known risk of narrow-angle glaucoma
- •Uncontrolled diabetes
- •Major trauma or surgery in the 2 months before screening
- •History of malignancy or treatment of malignancy in the last 5 years, excluding resected basal cell or squamous cell carcinoma of the skin
- •The participant is a pregnant or lactating woman or plans to become pregnant during the trial or within 70 days after the last dose administration
- •Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, long QT syndrome, personal history of syncope, or history of uncontrolled high blood pressure
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Olanzapine (Fast-D) 425mg
Experimental
Single-dose injection
干预措施: Olanzapine Extended Release (Drug)
Olanzapine (To-be-marketed) 425mg
Experimental
Single-dose injection
干预措施: Olanzapine Extended Release (Drug)
Olanzapine (Slow-C) 425mg
Experimental
Single-dose injection
干预措施: Olanzapine Extended Release (Drug)
ZYPREXA 5mg
Experimental
Single-dose injection
干预措施: Olanzapine Immediate Release (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
时间窗: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)
时间窗: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)
时间窗: Randomization Day 1 to 84 days after randomization
次要结局
- Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations(Randomization Day 1 through Randomization Day 29)
- Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations(Randomization Day 1 through Randomization Day 29)
- Cmax of ZYPREXA (Immediate-release Formulation)(Up to 24 hours after administration of ZYPREXA (Day 4))
- AUC0-t of ZYPREXA (Immediate-release Formulation)(Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13))
- Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)(Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13))
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Bioavailability of Five Mitopure FormulationsHealthy AdultsNCT06362018Amazentis SA60
已完成
1 期
Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy VolunteersHealthyNCT02036775Boehringer Ingelheim24
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT02000700Janssen Research & Development, LLC17
撤回
1 期
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)Lupus Erythematosus, SystemicNCT03771885Boehringer Ingelheim
已完成
1 期
Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male VolunteersEssential HypertensionNCT00937534Boryung Pharmaceutical Co., Ltd22