A Study to Evaluate the Safety and Tolerability of Subcutaneous Treprostinil and Pharmacokinetics of a Novel LY900014 Formulation in Healthy Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The aims of this study are to evaluate:
- The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
- The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.
The study has two parts. Participants may only enroll in one part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy Japanese
- •Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)
- •Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
排除标准
- •Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have participated in a clinical trial involving an investigational product within the 30 days before study entry.
- •Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
研究组 & 干预措施
Treprostinil (Part A)
Treprostinil administered as a single subcutaneous (SC) bolus injection.
干预措施: Treprostinil (Drug)
Placebo (Part A)
Placebo administered as a single SC bolus injection.
干预措施: Placebo (Drug)
LY900014 (Part B)
LY900014 (test) administered as a single SC bolus injection.
干预措施: LY900014 (Drug)
Insulin Lispro (Part B)
Insulin lispro (reference) administered as a single SC bolus injection.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Part A: Baseline through Study Completion (up to 14 Days after Last Dose)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
Pharmacokinetics (PK): Insulin Lispro Maximum Concentration (Cmax) (Part B)
时间窗: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose
PK: Insulin Lispro Cmax (Part B)
PK: Insulin Lispro Area Under the Concentration-Time Curve From Time Zero to 30 Minutes (AUC[0-30min]) (Part B)
时间窗: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 Minutes Postdose
PK: Insulin Lispro AUC(0-30min) (Part B)
次要结局
- PK: Treprostinil Time to Maximum Concentration (Tmax) (Part A)(15, 30, 60 and 120 Minutes Postdose)
- PK: Maximum Concentration (Cmax) of Treprostinil (Part A)(15, 30, 60 and 120 Minutes Postdose)