NCT01376063已完成1 期
A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- FibroGen
- 入组人数
- 20
- 主要终点
- Change in plasma concentration of Rosiglitazone
研究概览
简要总结
The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males, 18 to 45 years
- •Body weight ≥ 75 kg
- •Good health
- •Non-smoker
- •Blood pressure not greater than 140/90 mm Hg
排除标准
- •Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
- •Blood donation or significant blood loss within 60 days prior to Day 1
- •Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase
- •History or presence of alcoholism or drug abuse within 2 years prior to Day 1
- •Consumption of alcohol within 7 days prior to Day 1 or during treatment phase
- •Positive urine drug/alcohol testing at screening or check-in visit
研究组 & 干预措施
FG-4592
Experimental
干预措施: FG-4592 (Drug)
结局指标
主要结局
Change in plasma concentration of Rosiglitazone
时间窗: Day 1- Day 11
次要结局
- Change in plasma concentration of Rosiglitazone metabolites(Day 3 - Day 11)
研究者
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