NCT00488449已完成1 期
A Two-Part Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Oral Doses of GSK256073A, in a Randomized, Single-Blind, Dose Escalation Study in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing
研究概览
简要总结
The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 55 Years（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
结局指标
主要结局
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing
时间窗: throughout the study (Parts A &B)
Measures of accumulation ratios
时间窗: throughout the study (Ro, Rp, and Rs)[Part B]
AUC and Cmax
时间窗: throughout the study (Part A & B)
次要结局
- LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a)(on Days 1, 14, and 15.)
- Tmax, t½, Ae, and CLr (Parts A & B) Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios (Part B)(throughout the study)
- PD response: NEFA and TG (6 and 24 hours post- dose)((6 and 24 hours post- dose))
- Levels of GSK256073 to derive pharmacokinetic parameters following repeat dose administration.
- Lipid levels(on Days 1, 14, and 15)
研究者
研究点 (2)
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