An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects With Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Pharmacokinetic measurements for different injection sites after one dose.
研究概览
简要总结
This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
详细描述
An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A
In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen.
干预措施: GSK716155 subcutaneous injections (Drug)
Group B
In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
干预措施: GSK716155 subcutaneous injections (Drug)
Group C
In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen.
干预措施: GSK716155 subcutaneous injections (Drug)
Group D
In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm.
干预措施: GSK716155 subcutaneous injections (Drug)
Group E
In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg.
干预措施: GSK716155 subcutaneous injections (Drug)
Group F
In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
干预措施: GSK716155 subcutaneous injections (Drug)
Group G
In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm.
干预措施: GSK716155 subcutaneous injections (Drug)
Group H
In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg.
干预措施: GSK716155 subcutaneous injections (Drug)
结局指标
主要结局
Pharmacokinetic measurements for different injection sites after one dose.
时间窗: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
次要结局
- Pharmacodynamic measurements at three different times after one dose.(Up to Day 29)