An Open-Label Randomized, Crossover Study to Evaluate the Bioavailability of ABT-333 Tablets Versus Capsules, and A Double-blind, Randomized, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending Doses of ABT-333 Tablets Versus Placebo in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation
研究概览
简要总结
The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •overall healthy subjects;
- •non-childbearing potential females included
排除标准
- •history of significant sensitivity to any drug;
- •positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
- •history of gastrointestinal issues or procedures;
- •history of seizures, diabetes or cancer (except basal cell carcinoma);
- •clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
- •use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
- •donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
- •abnormal screening laboratory results that are considered clinically significant by the investigator;
- •current enrollment in another clinical study;
- •previous enrollment in this study;
- •recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
- •pregnant or breastfeeding female;
- •requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
研究组 & 干预措施
1. ABT-333 Capsule vs ABT-333 Tablet
400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose
干预措施: ABT-333 Tablet (Drug)
1. ABT-333 Capsule vs ABT-333 Tablet
400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose
干预措施: ABT-333 Capsule (Drug)
2. ABT-333 Tablet
ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)
干预措施: ABT-333 Tablet (Drug)
2. ABT-333 Tablet
ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)
干预措施: Placebo (Drug)
3. Placebo
Placebo tablets, QD, single ascending doses
干预措施: ABT-333 Tablet (Drug)
3. Placebo
Placebo tablets, QD, single ascending doses
干预措施: Placebo (Drug)
结局指标
主要结局
To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation
时间窗: 2 days post dosing
To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo
时间窗: 2 days post dosing
To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation
时间窗: 2 days post dosing
Pharmacokinetics
时间窗: 5 days
次要结局
未报告次要终点