An Open Label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of Gemfibrozil on the Single Dose Pharmacokinetics of ASP3652 and to Assess the Effect of Multiple Doses of ASP3652 on the Single Dose Pharmacokinetics of Repaglinide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Effect of multiple doses of gemfibrozil on the Pharmacokinetics (PK) of a single dose of ASP3652 (plasma) and metabolites H1/H2/H3
研究概览
简要总结
ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This is a two-part study to investigate the drug-drug potential of ASP3652.
Part I of the study evaluates the effect of gemfibrozil twice daily on the single dose of ASP3652.
Part 2 evaluates the effect of multiple doses of ASP3652 twice daily on the single dose of repaglinide.
Subjects participating in one part of the study may not participate in the other part.
详细描述
Part 1:
On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil.
Part 2:
On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is white and of Caucasian origin.
- •Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m
- •Male subjects must agree to practice an effective contraceptive method with female sexual partners to prevent pregnancy.
排除标准
- •Known or suspected hypersensitivity to ASP3652, repaglinide and/or gemfibrozil, or any components of the formulation used.
- •Any of the liver function tests (ALT, AST, γ-GT, TBL and ALP) above the upper limit of normal. In such case the sample may be repeated once.
- •Regular use of any inducer of metabolism (e.g. barbiturates, Rifampicin) in the 3 months prior to admission to the Clinical Unit.
研究组 & 干预措施
ASP3652 + repaglinide
Multiple doses of ASP3652 and the single dose of repaglinide
干预措施: Repaglinide (Drug)
gemfibrozil + ASP3652
Multiple doses of gemfibrozil and single dose of ASP3652
干预措施: ASP3652 (Drug)
gemfibrozil + ASP3652
Multiple doses of gemfibrozil and single dose of ASP3652
干预措施: Gemfibrozil (Drug)
ASP3652 + repaglinide
Multiple doses of ASP3652 and the single dose of repaglinide
干预措施: ASP3652 (Drug)
结局指标
主要结局
Effect of multiple doses of gemfibrozil on the Pharmacokinetics (PK) of a single dose of ASP3652 (plasma) and metabolites H1/H2/H3
时间窗: Days 1 - 11
Part 1: Maximum concentration (Cmax), AUClast and AUCinf
Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide and metabolite M4 (plasma)
时间窗: Days 1 - 10
Part 2: Cmax, AUClast, AUCinf, and the ratio AUC(M4) / AUC(repaglinide)
Assess the safety of single and multiple doses of ASP3652 alone and in combination with gemfibrozil or repaglinide
时间窗: Screening - End of Study Visit (7-14 days after (early) discharge)
Both Parts: Vital signs, physical examination, adverse events, electrocardiogram, clinical laboratory assessments, body temperature, Bond and Lader Visual Analogue Scale (VAS) questionnaire, Physician's Withdrawal Checklist (PWC)
次要结局
- Effect of multiple doses of gemfibrozil on the PK of a single dose of ASP3652 (plasma), metabolites H1/H2/H3 and Parent gemfibrozil and gemfibrozil-1-O-ß-glucuronide (plasma)(Days 1-11)
- Effect of multiple doses of ASP3652 on the PK of a single dose of repaglinide(Days 1-10)
- Effect of ASP3652 on the Pharmacodynamics (PD) of repaglinide by comparing the effect of repaglinide on blood glucose levels in the presence and absence of ASP3652(Days 1-10)