A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Analysis of pharmacokinetic results.
研究概览
简要总结
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics
详细描述
Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-333
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Main Selection Criteria for Healthy Volunteers:
- •Subject has provided written consent.
- •Subject is in general good health.
- •If female, subject is postmenopausal for at least 2 years or surgically sterile.
- •If female, subject is not pregnant and is not breast-feeding.
- •Male or female between 18 and 55 years old, inclusive.
- •If male, subject must be surgically sterile or practicing at least 1 method of birth control.
- •Body Mass Index (BMI) is 18 to 29, inclusive.
排除标准
- •See above for main selection criteria
研究组 & 干预措施
1
Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
干预措施: ABT-333 (Drug)
1
Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
干预措施: ketoconazole (Drug)
1
Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
干预措施: placebo (Drug)
2
Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
干预措施: ABT-333 (Drug)
2
Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
干预措施: placebo (Drug)
3
Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
干预措施: ABT-333 (Drug)
3
Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
干预措施: placebo (Drug)
4
Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
干预措施: ABT-333 (Drug)
4
Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
干预措施: placebo (Drug)
5
Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID*
*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.
干预措施: ABT-333 (Drug)
5
Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID*
*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.
干预措施: placebo (Drug)
结局指标
主要结局
Analysis of pharmacokinetic results.
时间窗: Approximately 1 week.
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
时间窗: Approximately 1 week.
次要结局
- Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.(Approximately 1 week.)