A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY110140 in Healthy Japanese Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period
研究概览
简要总结
The purposes of this study are to look at safety, how well the study drug (LY110140) is tolerated, and how much of the study drug gets into the blood stream when given as single dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will participate in SD portion for approximately 6 weeks and in MD portion for approximately 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product.
- •Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2), inclusive, at the time of screening.
- •Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.
排除标准
- •Poor metabolizers of isoenzyme cytochrome P450 2D6 (CYP2D6) (assessed at screening).
- •Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT (QTcB) interval >450 milliseconds (msec).
- •Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS).
- •Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.
研究组 & 干预措施
20 mg LY110140 (SD)
20 mg administered once in the fasted state on Day 1
干预措施: LY110140 (Drug)
5 milligrams (mg) LY110140 (SD)
5 mg administered once in the fasted state on Day 1
干预措施: LY110140 (Drug)
40 mg LY110140 (SD)
40 mg administered once in the fasted state on Day 1
干预措施: LY110140 (Drug)
Placebo (MD)
Placebo once daily oral dosing for 28 consecutive days
干预措施: Placebo (Drug)
20 mg LY110140 (MD)
20 mg once daily oral dosing for 28 consecutive days
干预措施: LY110140 (Drug)
40 mg LY110140 (MD)
40 mg once daily oral dosing for 28 consecutive days
干预措施: LY110140 (Drug)
结局指标
主要结局
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period
时间窗: Baseline up to Day 43
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period
时间窗: Baseline up to Day 70
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140(Predose up to Day 43)
- Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140(Predose up to Day 43)
- Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140(Predose up to Day 43)
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140(Days 1 and 28)
- Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals(Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period))
- Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140(Day 1)
- Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140(Predose up to Day 28)