A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) for DTG
研究概览
简要总结
The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent
- •Target population: Healthy males and females.
- •Women of child bearing potential (WOCBP) with negative serum pregnancy test
- •Women must not be breastfeeding
- •Men and WOCBP must agree to follow instructions for contraception
排除标准
- •History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
- •History of frequent headaches or acute diarrhoea.
- •Any major surgery within 4 weeks of study drug administration
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- •History of allergy to HIV maturation and integrase inhibitors,or related compounds
- •History of smoking
研究组 & 干预措施
Treatment A
Single DTG tablet under fed conditions for a specified period
干预措施: Dolutegravir (Drug)
Treatment B
Two BMS955176 tablets under fed conditions for a specified period
干预措施: BMS955176 (Drug)
Treatment C
Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period
干预措施: Dolutegravir (Drug)
Treatment C
Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period
干预措施: BMS955176 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) for DTG
时间窗: Days 1 to 5 and days 15 to 21
Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG
时间窗: Days 1 to 5 and days 15 to 21
Maximum observed plasma concentration (Cmax) for BMS-955176
时间窗: Days 8-21
Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176
时间窗: Days 8-21
次要结局
- Adverse events (AEs)(Days 1-21; for SAEs up to 30 days post discontinuation of dosing)