Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
研究概览
简要总结
The purposes of this study are:
- To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)
- To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous [SC]) (Part B).
Information about any side effects that may occur will also be collected. Each part of the study will last about six months. 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
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy participants
- •Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive
排除标准
- •Currently smoke in excess of 5 cigarettes/day
研究组 & 干预措施
Galcanezumab Solution Formulation-Part A
Galcanezumab solution formulation in a prefilled syringe given SC once.
干预措施: Galcanezumab (Drug)
Placebo-Part A
Placebo in a prefilled syringe given SC once.
干预措施: Placebo (Drug)
Galcanezumab Lyophilized Formulation-Part B
Galcanezumab lyophilized (freeze dried) formulation given SC once.
干预措施: Galcanezumab (Drug)
Galcanezumab Solution Formulation-Part B
Galcanezumab solution formulation in a prefilled syringe given SC once.
干预措施: Galcanezumab (Drug)
结局指标
主要结局
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
时间窗: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
Part A: Number of Participants With an Injection Site Adverse Event
时间窗: Part A: Predose through 48 hours post dose
If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab
时间窗: Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.
次要结局
- Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)(Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose)
- Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP(Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose)
- Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)(Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose)
- Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP(Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose)
- Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)(Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose)
- Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)(Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose)