A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
研究概览
简要总结
This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.
详细描述
On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult volunteers in general good health.
- •Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Individuals between 18 and 55 years of age inclusive at the time of screening.
- •Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m
- •All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
- •All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.
排除标准
- •Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
- •Pregnant or breastfeeding.
- •Treatment with any other investigational treatment within 30 days
研究组 & 干预措施
Period 1, 2 and 3 ABBV-CLS-7262
- Participants will receive ABBV-CLS-7262 administered under fasted conditions.
- Participants will receive ABBV-CLS-7262 administered under fed conditions (high-fat/high-calorie breakfast).
- Participants will receive ABBV-CLS-7262 administered with applesauce.
干预措施: ABBV-CLS-7262 (Drug)
结局指标
主要结局
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
时间窗: Approximately Two Weeks
Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.
时间窗: Approximately Two Weeks
Maximum Plasma Concentration \[Cmax\]; Area under the Curve (AUC)
次要结局
- Safety and Tolerability(Approximately Six Weeks)