NCT05763459已完成1 期
A Phase 1 Study to Evaluate the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Rosuvastatin
研究概览
简要总结
This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
详细描述
Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.
Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.
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 65 Years（Adult, Older 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 65 years of age inclusive at the time of screening
- •BMI is ≥ 18.0 to ≤ 32.0 kg/m2
- •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
ABBV-CLS-7262
Experimental
ABBV-CLS-7262 + Digoxin + Rosuvastatin
干预措施: ABBV-CLS-7262 (Drug)
结局指标
主要结局
Pharmacokinetics of Rosuvastatin
时间窗: Two Weeks
Area under the Curve (AUC)
Pharmacokinetics of Digoxin
时间窗: Two Weeks
Area under the Curve (AUC)
次要结局
- Safety and Tolerability(Two Weeks)
研究者
研究点 (1)
Loading locations...
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