A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.
详细描述
Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33
排除标准
- •Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
- •Use of any prescribed systemic or topical medication within 30 days of the first dose;
- •Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
- •Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration
研究组 & 干预措施
50 mg of AVL-292 and Placebo
50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition
干预措施: 50 mg AVL-292 (Drug)
Placebo - 8 capsules
8 placebo capsules once daily for 7 days administered orally under fasted condition
干预措施: Placebo capsules (Drug)
50 mg of AVL-292 and Placebo
50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition
干预措施: Placebo capsules (Drug)
100 mg of AVL-292 and Placebo
100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition
干预措施: 100 mg AVL-292 (Drug)
100 mg of AVL-292 and Placebo
100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition
干预措施: Placebo capsules (Drug)
200 mg AVL-292
8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition
干预措施: 200 mg AVL-292 (Drug)
350 mg of AVL-292
350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition
干预措施: 350 mg AVL-292 (Drug)
Placebo - 14 capsules
14 placebo capsules once daily for 7 days administered orally under fasted condition
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 28 days after last AVL-292 dose
Number of participants with adverse events
PK-(Cmax)
时间窗: 24 hours after the last AVL-292 dose on days 1 and 7
Maximum observed concentration in plasma
PK-(AUC)
时间窗: 24 hours after the last AVL-292 dose days 1 and 7
Area under the plasma concentration-time curve
次要结局
- Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells(24 hours after the last AVL-292 dose days 1 and 7)