Safety and Tolerability of LY3154207 in Combination With a CYP3A4 Inhibitor and Assessment of Pharmacokinetics of LY3154207 After Administration of Capsule and Tablet Formulations in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
研究概览
简要总结
The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
The capsule versus tablet formulation comparison will be open label.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m²)
- •Have clinical laboratory test results within acceptable range for the population
排除标准
- •Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
- •Intend to use over-the-counter or prescription medication (with exception of hormonal contraceptives and acetaminophen), including herbal preparations containing St. John's wort, kava, garlic, ginger, ginkgo biloba, or guarana, within 14 days prior to Check-in and during the study
- •Use of any drugs or substances that are known inducers and/or inhibitors of cytochrome P450 (CYP) 3A within 14 days prior to the administration of study drug and during the study
- •Have evidence of active renal disease (eg, diabetic renal disease, polycystic kidney disease) or an estimated creatinine clearance of < 80 milliliters per minute (mL/minute), calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
研究组 & 干预措施
Cohort 2 - Placebo + Fluconazole
Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
干预措施: Placebo (Drug)
Cohort 1 Part A - LY3154207 Capsule
LY3154207 capsule (reference) administered orally, once.
干预措施: LY3154207 Capsule (Drug)
Cohort 1 Part A - LY3154207 Tablet
LY3154207 tablet (test) administered orally, once.
干预措施: LY3154207 Tablet (Drug)
Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole
LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
干预措施: LY3154207 Tablet (Drug)
Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole
LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
干预措施: Fluconazole Tablet (Drug)
Cohort 1 Part B - Placebo + Fluconazole
Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
干预措施: Placebo (Drug)
Cohort 1 Part B - Placebo + Fluconazole
Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
干预措施: Fluconazole Tablet (Drug)
Cohort 2 - LY3154207 (Dose 2) + Fluconazole
LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
干预措施: LY3154207 Tablet (Drug)
Cohort 2 - LY3154207 (Dose 2) + Fluconazole
LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
干预措施: Fluconazole Tablet (Drug)
Cohort 2 - Placebo + Fluconazole
Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
干预措施: Fluconazole Tablet (Drug)
Cohort 3 - LY3154207 + Fluconazole
LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
干预措施: LY3154207 Tablet (Drug)
Cohort 3 - LY3154207 + Fluconazole
LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days.
干预措施: Fluconazole Tablet (Drug)
Cohort 3 - Placebo + Fluconazole
Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
干预措施: Placebo (Drug)
Cohort 3 - Placebo + Fluconazole
Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days.
干预措施: Fluconazole Tablet (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
时间窗: Baseline up to 11 weeks
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Change from Baseline in Blood Pressure (BP)(Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole)
- PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207(Baseline up to 48 hours postdose)
- PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207(Baseline up to 48 hours postdose)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207(Baseline up to 48 hours postdose)
- Change from Baseline in Pulse Rate (PR)(Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole)