A Phase 1, Randomized, Participant-and Investigator-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose, Drug-Drug Interaction and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3509754 in Healthy Non-Japanese and Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 2
- 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
The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.
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)
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
- •Overtly healthy males or females, as determined by medical history and physical examination.
- •Body mass index (BMI) within the range of 18 to 35 kilograms per meter squared (kg/m²) in Parts A, B, and C. In Part D (Japanese participants), body weight between 50 and 85 kg and BMI within the range of 18 to 28 kg/m².
排除标准
- •Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY
- •Women of childbearing potential are excluded from the trial.
研究组 & 干预措施
Placebo plus Itraconazole - Part B
Placebo and 200 mg Itraconazole were administered orally.
干预措施: Itraconazole (Drug)
LY3509754 - Part A
Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally.
干预措施: LY3509754 (Drug)
Placebo - Part A
Placebo was administered orally.
干预措施: Placebo (Drug)
LY3509754 plus Itraconazole - Part B
10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.
干预措施: LY3509754 (Drug)
LY3509754 plus Itraconazole - Part B
10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.
干预措施: Itraconazole (Drug)
Placebo plus Itraconazole - Part B
Placebo and 200 mg Itraconazole were administered orally.
干预措施: Placebo (Drug)
LY3509754 plus Midazolam - Part C
Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.
干预措施: LY3509754 (Drug)
LY3509754 plus Midazolam - Part C
Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.
干预措施: Midazolam (Drug)
Placebo plus Midazolam - Part C
Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.
干预措施: Placebo (Drug)
Placebo plus Midazolam - Part C
Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.
干预措施: Midazolam (Drug)
LY3509754 (Japanese) - Part D
Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants.
干预措施: LY3509754 (Drug)
Placebo (Japanese) - Part D
Placebo was administered orally to Japanese participants.
干预措施: Placebo (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: Baseline up to Day 26
An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B(Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.)
- PK: Cmax of LY3509754 in Parts C and D(Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.)
- PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B(Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.)
- PK: AUC(0-24) of LY3509754 in Parts C and D(Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.)