An Open-Label, Single-Dose, 4-Way Crossover, Bioavailability Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Food Effect of BBI-5000 Capsules in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
研究概览
简要总结
To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
详细描述
This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.
Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.
PK and PD will be assessed by blood sampling through 72 hours postdose.
Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoker
- •Medically healthy
- •32.0 >= BMI >= 18.5 kg/m^2
- •Weight >= 50 kg for males
- •Weight >= 45 kg for females
- •For a female of childbearing potential: either be sexually inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method as dictated by the study
- •Willing to comply with protocol and understands study procedures outlined in the ICF
排除标准
- •Subject is mentally or legally incapacitated or has significant emotional problems
- •History or presence of medical or psychiatric disease
- •History of any illness that might confound the results of the study
- •History or presence of alcoholism or drug abuse
- •History or presence of hypersensitivity or idiosyncratic reaction the the study drug excipient
- •History or presence of lactose intolerance
- •Pregnant or lactating females
- •Seated blood pressure less than 90/40 mmHg or greater than 140/90 mmHg
- •Seated heart rate lower than 40 bpm or higher than 99 bpm
- •Unable to refrain from or anticipates the use of any drug
- •Diet incompatible with the on-study diet
- •Donation of blood or significant blood loss within 56 days prior to the first study dose
- •Participation in another clinical trial within 28 days prior to the first study dose
研究组 & 干预措施
BBI-5000 Dose 4
High dose of BBI-5000
干预措施: BBI-5000 (Drug)
BBI-5000 Dose 1
Low dose of BBI-5000
干预措施: BBI-5000 (Drug)
BBI-5000 Dose 2
Middle dose of BBI-5000
干预措施: BBI-5000 (Drug)
BBI-5000 Dose 3
High dose of BBI-5000
干预措施: BBI-5000 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) for BBI-5000 and 3 metabolites
时间窗: Week 4
Time of Occurrence of Cmax (Tmax)
时间窗: Week 4
Half-life for BBI-5000 and the 3 metabolites
时间窗: Week 4
Plasma concentrations after single dosing of BBI-5000 for BBI-5000 and 3 metabolites
时间窗: Week 4
Area Under Curve (AUC) for BBI-5000 and 3 metabolites
时间窗: Week 4
Terminal plasma elimination rate constant for BBI-5000 and the 3 metabolites
时间窗: Week 4
Clearance (CL/F)
时间窗: Week 4
BBI-5000 concentrations in plasma after dosing in fed and fasted conditions
时间窗: Week 4
次要结局
- Safety and tolerability as measured by assessment of treatment-related adverse events, safety laboratory, vital signs, electrocardiogram and physical examination results(Week 4)