A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Cyclosporine on the Pharmacokinetics of LY3502970 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- PK: Maximum Observed Concentration (Cmax) of LY3502970
研究概览
简要总结
The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation
- •Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
- •Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
- •Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
排除标准
- •Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Participants who regularly use known drugs of abuse
- •Women who are lactating and who are of child-bearing potential
- •Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
研究组 & 干预措施
Midazolam + LY3502970
Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1.
干预措施: Midazolam (Drug)
Midazolam + LY3502970
Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1.
干预措施: LY3502970 (Drug)
Cyclosporine + Midazolam + LY3502970
Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.
干预措施: Midazolam (Drug)
Cyclosporine + Midazolam + LY3502970
Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.
干预措施: LY3502970 (Drug)
Cyclosporine + Midazolam + LY3502970
Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.
干预措施: Cyclosporine (Drug)
结局指标
主要结局
PK: Maximum Observed Concentration (Cmax) of LY3502970
时间窗: Predose up to 96 hours postdose
PK: Cmax of LY3502970
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
时间窗: Predose up to 96 hours postdose
PK: AUC of LY3502970
次要结局
未报告次要终点