Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Cytochrome P450 Interaction Study of LY3154207 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 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 Administration
研究概览
简要总结
This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.
Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.
Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.
Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.
Participants may only enroll in 1 of the 3 parts of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Overtly healthy males or females, as determined by medical history and physical examination
- •Female participants not of child-bearing potential
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Have given written informed consent
- •Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)
排除标准
- •Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
- •Part C only: Have known allergy or contraindications to itraconazole
研究组 & 干预措施
LY3154207 (Part A)
LY3154207 administered in ascending doses once orally in two of three study periods
干预措施: LY3154207 (Drug)
Placebo (Part A)
Placebo matching LY3154207 administered once orally in one of three study periods.
干预措施: Placebo (Drug)
LY3154207 (Part B)
LY3154207 administered once orally.
干预措施: LY3154207 (Drug)
Placebo (Part B)
Placebo matching LY3154207 administered once orally.
干预措施: Placebo (Drug)
LY3154207 (Part C)
LY3154207 administered once orally on Day 1
干预措施: LY3154207 (Drug)
LY3154207 + Itraconazole (Part C)
Itraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A.
干预措施: LY3154207 (Drug)
LY3154207 + Itraconazole (Part C)
Itraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A.
干预措施: Itraconazole (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 Administration
时间窗: Up to 48 hours after administration of study drug
次要结局
- Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207(Predose through 48 hours after administration of study drug)
- Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207(Predose through 48 hours after administration of study drug)
- Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207(Predose through 48 hours after administration of study drug)
- Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207(Predose through 48 hours after administration of study drug)
- Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole(Predose through 96 hours after administration of study drug)
- Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole(Predose through 96 hours after administration of study drug)