A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
研究概览
简要总结
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 否
入选标准
- •Signed Informed Consent
- •Target population: Subjects on methadone maintenance therapy (for inclusion in Part 1) or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in Part 2), who have been reliably participating in an oral methadone or buprenorphine and norbuprenorphine program and who are on a stable dose for at least 30 days prior to study screening
- •Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
- •Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and 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, smoking and alcohol abuse
- •Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption
- •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 any drugs, BMS-663068, HIV attachment inhibitors, or related compounds
研究组 & 干预措施
Part 1 (BMS-663068+methadone)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
干预措施: BMS-663068 (Drug)
Part 1 (BMS-663068+methadone)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
干预措施: Methadone (Drug)
Part 2 (BMS-663068+buprenorphine and norbuprene)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
干预措施: BMS-663068 (Drug)
Part 2 (BMS-663068+buprenorphine and norbuprene)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
干预措施: Buprenorphine and Norbuprenorphine (Drug)
结局指标
主要结局
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
时间窗: Days 1 to 10
AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
时间窗: Days 1 to 10
次要结局
- Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.(For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and up to 30 days post discontinuation of dosing)