NCT06315283已完成1 期
A 21-Week, Multicenter, Open-Label, Multiple-Dose Trial to Assess the Comparative Bioavailability of Olanzapine Prolonged-Release Suspension for Subcutaneous Administration (TV-44749) to Oral Olanzapine (European Reference) in Participants With Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 9
- 主要终点
- Area under the curve (AUC) of TV-44749
研究概览
简要总结
The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.
A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia.
Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.
The total duration of participation in the trial for each participant is planned to be approximately 21 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the trial until completion of the EOT or 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 period).
- •Have a current confirmed diagnosis of schizophrenia according to an evaluation by the Investigator, as defined by the DSM-5 (American Psychiatric Association 2013a).
- •Are clinically stable on oral olanzapine 20 mg daily (ie, dose has not changed in the last 4 weeks) and not currently on other antipsychotic treatments at the time of screening. Participants on alternative olanzapine regimens (eg, 10 mg twice daily) may be considered for inclusion in the trial based upon the Investigator's clinical judgment.
- •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 (postmenopausal status will be confirmed by a follicle-stimulating hormone screen according to the clinical laboratory standard value) for at least 1 year; or they are practicing a highly effective method of birth control and not planning pregnancy for at least 30 days before the trial, for the duration of the trial, and for 70 days after the last dose administration, if they are sexually active and of childbearing potential.
- •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
- •History or known risk of narrow-angle glaucoma.
- •History or a complication of diabetes (hemoglobin A1c 6.5% or above and/or fasting plasma glucose 126 mg/dL or above).
- •Evidence of significant hepatic disorder.
- •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.
- •Known hypersensitivity or idiosyncratic reaction to olanzapine (or unable to tolerate oral olanzapine dose) or any of the excipients of TV-44749 in any formulation, their related compounds, or to any metabolites, or any compound listed as being present in TV-44749 or oral olanzapine.
- •Presence of excessive pigment, bruises, scars, or tattoos around the potential injection area.
- •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. Participants with history of high blood pressure who no longer require treatment or participants who are treated with antihypertensive medications and whose blood pressure is currently well-controlled, may be enrolled.
- •Substance use disorder criteria for alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) have been met within the past 12 months prior to screening as defined by the DSM-5 (American Psychiatric Association 2013b).
- •A current clinically significant DSM-5 diagnosis other than schizophrenia.
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Oral olanzapine
Active Comparator
干预措施: Oral olanzapine (Drug)
TV-44749
Experimental
干预措施: TV-44749 (Drug)
结局指标
主要结局
Area under the curve (AUC) of TV-44749
时间窗: Days 57 to 85
AUC of oral olanzapine
时间窗: 24-hour period following administration of the 7th dose
次要结局
- Cmax,ss of oral olanzapine(24-hour period following administration of the 7th dose)
- Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749(Days 1 to 113)
- Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749(Days 1 to 113)
- Number of participants with at least one injection site adverse event during treatment with TV-44749(Days 1 to 113)
- Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749(Day 57 to Day 85)
- Plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of TV-44749(Day 85)
- Cmin,ss of oral olanzapine(24-hour period following administration of the 7th dose)
- Ctrough,ss of oral olanzapine(24-hour period following administration of the 7th dose)
研究者
研究点 (9)
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