A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Participants With Bipolar I Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Number of Participants Who Experience One or More Adverse Events (AEs)
研究概览
简要总结
The goal of this study is to evaluate the safety and tolerability of elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness.
- •History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
- •Body mass index is 18 and 40 kg/m^2, inclusive.
- •If currently taking an antipsychotic, is able to discontinue use at least 5 days prior to study start and the duration of the study.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- •Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
- •History of cancer (malignancy).
- •Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
- •History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
- •Substance-induced psychotic disorder or behavioral disturbance.
- •DSM-5 TR defined substance use disorder within 3 months of screening.
- •History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
- •Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
- •Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
- •Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention.
研究组 & 干预措施
Panel C: Placebo
Participants received Panel C MK-8189-matching placebo QD for 14 days.
干预措施: Placebo (Drug)
Panel A: Placebo
Participants received Panel A MK-8189-matching placebo QD for 14 days.
干预措施: Placebo (Drug)
Panel B: Placebo
Participants received Panel B MK-8189-matching placebo for 14 days.
干预措施: Placebo (Drug)
Panel A: 24 mg Elpipodect
Participants received 24 mg elpipodect once daily (QD) for 14 days.
干预措施: Elpipodect (Drug)
Panel B: 16 & 24 mg Elpipodect
Participants received 16 mg elpipodect QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14.
干预措施: Elpipodect (Drug)
Panel C: 8, 16, & 24 mg Elpipodect
Participants received 8 mg elpipodect Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14.
干预措施: Elpipodect (Drug)
结局指标
主要结局
Number of Participants Who Experience One or More Adverse Events (AEs)
时间窗: Up to 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to 14 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
未报告次要终点