NCT01913379已完成1 期
A Phase I Randomized, Open-label, 3-arm Parallel-design Study to Determine the Effect of Multiple-dose Gemfibrozil or Itraconazole on the Pharmacokinetics, Safety and Tolerability of Single-dose MDV3100 (ASP9785) in Healthy Male 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
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetic profile of MDV3100 by Cmax (Maximum concentration)
研究概览
简要总结
A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100 and Itraconazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Body weight of at least 65.0 kg and no greater than 85.0 kg.
- •Body Mass Index (BMI) of at least 18.5 and no greater than 30.0 kg/m2.
排除标准
- •Known or suspected hypersensitivity to MDV3100, itraconazole, gemfibrozil, any components of the formulations used, or any history of liver toxicity with other drugs.
- •Confirmed CYP2C8 PM status based on genotyping analysis.
- •Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
- •History of seizure, including any febrile seizure, loss of consciousness, or transient ischemia attack within 12 months prior to enrollment (Day 1 visit), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
- •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
- •Abnormal pulse and/or blood pressure (BP) measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic BP >140 mmHg ; mean diastolic BP >90 mmHg (BP measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
- •A QTc interval of >430 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
- •Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
- •Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
研究组 & 干预措施
1: MDV3100
Experimental
干预措施: MDV3100 (Drug)
2: MDV3100 and gemfibrozil
Experimental
干预措施: MDV3100 (Drug)
2: MDV3100 and gemfibrozil
Experimental
干预措施: Gemfibrozil (Drug)
3: MDV3100 and itraconazole
Experimental
干预措施: MDV3100 (Drug)
3: MDV3100 and itraconazole
Experimental
干预措施: Itraconazole (Drug)
结局指标
主要结局
Assessment of pharmacokinetic profile of MDV3100 by Cmax (Maximum concentration)
时间窗: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUCinf (AUC extrapolated to infinity)
时间窗: Day 1 through Day 53 (29 times)
Assessment of pharmacokinetic profile of MDV3100 by AUC0-432h (AUC from the time of dosing to 432 hours post-dose)
时间窗: Day 1 through Day 53 (29 times)
次要结局
- Assessment of pharmacokinetic profile of MDV3100(Day 1 through Day 53 (29 times))
- Assessment of pharmacokinetic profile of the metabolites MDPC0001 and MDPC0002(Day 1 through Day 53 (29 times))
- Assessment of metabolite-to-parent ratios for MDV3100(Day 1 through Day 53 (29 times))
- Assessment of Gemfibrozil and gemfibrozil 1-O-β-glucuronide (Arm 2)(Day 1 through Day 53 (50 times))
- Assessment of itraconazole and hydroxyitraconazole (Arm 3)(Day 1 through Day 53 (50 times))
- Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)(Day 1 through Day 53)
研究者
研究点 (1)
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