A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, TWO SEQUENCE, 3-WAY CROSSOVER STUDY TO INVESTIGATE THE INTERACTION BETWEEN MULTIPLE DOSES OF COLISTIN METHANESULFONATE SODIUM (CMS) AND MULTIPLE DOSES OF RO7033877 IN HEALTHY SUBJECTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)
研究概览
简要总结
This single center, open-label, randomized study will investigate the drug-drug interaction potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate sodium (CMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male or female (of non childbearing potential) healthy volunteers between 18 to 55 years
- •Body mass index (BMI) between 18 and 30 kg/m2
- •Non smokers
- •Use adequate contraception methods
排除标准
- •Evidence of active of chronic disease
- •Regular consumption of drugs of abuse
- •Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
- •History of significant allergic reactions
- •Abnormal blood pressure
- •Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
研究组 & 干预措施
Treatment Sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, RO7033877; Period 2, CMS; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
干预措施: CMS (Drug)
Treatment Sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, RO7033877; Period 2, CMS; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
干预措施: RO7033877 (Drug)
Treatment Sequence 1
Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, RO7033877; Period 2, CMS; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
干预措施: RO7033877 + CMS (Drug)
Treatment Sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 2 is: Period 1, CMS; Period 2, RO7033877; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
干预措施: CMS (Drug)
Treatment Sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 2 is: Period 1, CMS; Period 2, RO7033877; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
干预措施: RO7033877 (Drug)
Treatment Sequence 2
Participants will be randomized to one of two treatment sequences. Sequence 2 is: Period 1, CMS; Period 2, RO7033877; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.
干预措施: RO7033877 + CMS (Drug)
结局指标
主要结局
Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)
时间窗: up to 4 days (for each period)
次要结局
- Incidence of adverse events (AEs)(Up to 9 weeks)