A Phase 1, Open-label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Clarithromycin 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
- 26
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) 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 clarithromycin in healthy participants. This study will last up to approximately 85 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
Clarithromycin + LY3502970 (Period 2)
Participants received below:
Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H).
Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.
Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later
干预措施: Clarithromycin (Drug)
LY3502970 alone (Period 1)
Participants received a single 3 milligram (mg) dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.
干预措施: LY3502970 (Drug)
Clarithromycin + LY3502970 (Period 2)
Participants received below:
Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H).
Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally.
Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later
干预措施: LY3502970 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
时间窗: Predose up to 120 hours postdose
PK: AUC of LY3502970
PK: Maximum Observed Concentration (Cmax) of LY3502970
时间窗: Predose up to 120 hours postdose
PK: Cmax of LY3502970
次要结局
未报告次要终点