A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Area under the plasma concentration-time curve from 0-t (AUC0-t)
研究概览
简要总结
The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers
- •Ages 18 to 60 years, inclusive
- •A body mass index (BMI) between 18 to 32 kg/m2, inclusive
- •Agreement to comply with study restrictions
排除标准
- •History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities
- •Electrocardiogram (EGC) or vital signs abnormalities
- •Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
- •Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
- •Pregnant or lactating
- •Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
研究组 & 干预措施
Combination therapy RG1662 + itraconazole
Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food
干预措施: RG1662 (Drug)
Combination therapy RG1662 + itraconazole
Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food
干预措施: itraconazole (Drug)
RG1662 Monotherapy
Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.)
干预措施: RG1662 (Drug)
itraconazole Monotherapy
Days 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose)
干预措施: itraconazole (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from 0-t (AUC0-t)
时间窗: Within 29 days
Maximum observed plasma concentration (Cmax)
时间窗: Within 29 days
Time to maximum observed plasma concentration (Tmax)
时间窗: Within 29 days
次要结局
- Clinically significant changes from baseline in physical examination or laboratory parameters(Within 29 days)
- Change from baseline in QTcF(Up to 29 days)
- Incidence of adverse events(Within 43 days)
- Mean model parameters of RG1662 concentration vs. QTcF changes(Within 29 days)