A Single-Dose, Open-Label, Two-Part, Randomized, Crossover Formulation Bridging and Food Effect Study to Assess the Effect of Formulation and Food on the Absorption and Bioavailability of PBI-200 in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration [C(max)] of PBI-200
研究概览
简要总结
This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.
详细描述
This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive).
- •Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive).
- •Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.
排除标准
- •History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
- •History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
- •Intolerance to repeated venipuncture.
- •Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
- •Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
- •Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.
研究组 & 干预措施
Capsule
Study drug will be administered with water after an overnight fast.
干预措施: PBI-200 Capsule (Drug)
Tablet
Study drug will be administered with water after an overnight fast.
干预措施: PBI-200 Tablet (Drug)
Suspension
Study drug will be administered with water after an overnight fast.
干预措施: PBI-200 Suspension (Drug)
Fasted
Study drug will be administered with water after an overnight fast.
干预措施: PBI-200 Tablet (Drug)
Low-fat Meal
Study drug will be administered with water after an overnight fast, after which time a standard low-fat breakfast will be given.
干预措施: PBI-200 Tablet (Drug)
High-fat Meal
Study drug will be administered with water after an overnight fast, after which time a standard high-fat breakfast will be given.
干预措施: PBI-200 Tablet (Drug)
结局指标
主要结局
Maximum Plasma Concentration [C(max)] of PBI-200
时间窗: 8 days
Maximum (peak) plasma drug concentration
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of th last measurable concentration [AUC(0-t)]
时间窗: 8 days
AUC, calculated using linear up / log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.
AUC of PBI-200 from time zero to infinity [AUC(0-inf)]
时间窗: 8 days
AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/kel, where kel is the terminal rate constant and Ct is the last measurable concentration.
次要结局
- Terminal elimination half-life [T(1/2)](8 days)
- Time to Maximum Concentration [T(max)] of PBI-200(8 days)
- Incidence, frequency and severity of adverse events (AEs)(14 days)