A Randomized, Single-center, Open-label, One-sequence, Two-period Crossover Study in 3 Parts to Investigate the Effects of Multiple Doses of Ketoconazole (Part 1), Rifampicin (Part 2), and Ritonavir-boosted Atazanavir (Part 3) on the PK of a Single Dose of RO5093151 in Healthy Female & Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
研究概览
简要总结
This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, 18 to 65 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination
- •Body mass index (BMI) 18 to 30 kg/m2
- •Females of child-bearing potential must agree to use two effective methods of contraception, including a barrier method and an intrauterine non-hormonal device (set in place at least 3 months before first dosing) for the duration of the study and at least 1 month after last dosing
- •Non-smoker for at least 90 days prior to screening
排除标准
- •Pregnant or lactating females
- •History of drug abuse in the past 2 years, or suspicion of regular consumption of drugs of abuse, or positive result on drugs of abuse test
- •History of alcoholism in the past 2 years, or positive alcohol test
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Systemic , topical, intranasal or inhaled corticosteroid therapy for more than 2 weeks within 3 months prior to screening
- •Participation in an investigational drug or device study within 90 days prior to screening
研究组 & 干预措施
1 Ketoconazole DDI
干预措施: RO5093151 (Drug)
1 Ketoconazole DDI
干预措施: ketoconazole (Drug)
2 Rifampicin DDI
干预措施: RO5093151 (Drug)
2 Rifampicin DDI
干预措施: rifampicin (Drug)
3 ATZ/r DDI
干预措施: RO5093151 (Drug)
3 ATZ/r DDI
干预措施: atazanavir (Drug)
3 ATZ/r DDI
干预措施: ritonavir (Drug)
结局指标
主要结局
Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 72 hours post-dose
Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 72 hours post-dose
Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 72 hours post-dose
次要结局
- Safety: Incidence of adverse events(approximately 6 month)
- RO5093151 metabolites: Plasma/urine concentrations(Pre-dose and up to 72 hours post-dose)
- Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)(Pre-dose and up to 24 hours post-dose)