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临床试验/NCT02323334
NCT02323334已完成1 期

Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2014年12月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
94
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
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study involves single and multiple doses of LY3202626 and will evaluate the effects of LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single increasing doses of LY3202626 will be given in capsule form. Part A will also include itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days with the study drug. Part C will last approximately 11-14 weeks. Part D will last approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may only enroll in one part.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •For Parts A, B, and C, are overtly healthy males or females (nonchildbearing potential), as determined by medical history and physical examination
  • •Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)
  • •For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild to moderate AD
  • •Have venous access sufficient to allow for blood sampling
  • •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and research unit policies

排除标准

  • •Taking over-the-counter or prescription medication with the exception of vitamins or minerals
  • •Smoke more than 10 cigarettes per day
  • •Are unwilling or unable to refrain from eating any food or drinking any beverage containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose until completion of the study

研究组 & 干预措施

Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg

Placebo Comparator

Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg placebo (PBO) Period 4: 15mg LY3202626.

干预措施: LY3202626 (Drug)

Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg

Placebo Comparator

Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg placebo (PBO) Period 4: 15mg LY3202626.

干预措施: Placebo (Part A, B, C) (Drug)

Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg

Experimental

Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.1mg Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626.

干预措施: LY3202626 (Drug)

Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg

Experimental

Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.1mg Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626.

干预措施: Placebo (Part A, B, C) (Drug)

Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra

Experimental

Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg LY3202626 Period 2: 5mg, PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: Itraconazole (Drug)

Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo

Experimental

Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO.

干预措施: LY3202626 (Drug)

Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo

Experimental

Part A Cohort 1 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO.

干预措施: Placebo (Part A, B, C) (Drug)

Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole

Experimental

Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg LY3202626 Period 2: 5mg LY3202626 Period 3: 45mg, PBO Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: LY3202626 (Drug)

Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole

Experimental

Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg LY3202626 Period 2: 5mg LY3202626 Period 3: 45mg, PBO Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: Placebo (Part A, B, C) (Drug)

Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra

Experimental

Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg LY3202626 Period 2: 5mg, PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: LY3202626 (Drug)

Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra

Experimental

Part A Cohort 2 involved healthy participants and comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg LY3202626 Period 2: 5mg, PBO Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: Placebo (Part A, B, C) (Drug)

Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra

Experimental

Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg, PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: LY3202626 (Drug)

Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra

Experimental

Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg, PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: Placebo (Part A, B, C) (Drug)

Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra

Experimental

Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods with a washout period of approximately 14 days between doses.

Period 1: 0.4mg, PBO Period 2: 5mg LY3202626 Period 3: 45mg LY3202626 Period 4: 0.4mg LY3202626/200mg Itraconazole.

干预措施: Itraconazole (Drug)

Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted

Experimental

Part A Cohort 3 involved healthy participants and was comprised of two treatment periods with a washout period of approximately 14 days between doses. Single dose of 10mg LY3202626 given PO in Period 1 and 2. Period 1: Fed 2: Fasted.

干预措施: LY3202626 (Drug)

Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed

Experimental

Part A Cohort 3 involved healthy participants and was comprised of two treatment periods with a washout period of approximately 14 days between doses. Single dose 10mg LY3202626 given PO in Period 1 and 2. Period 1: Fasted 2: Fed.

干预措施: LY3202626 (Drug)

Part B Cohort 4: 1.6mg

Experimental

Part B Cohort 4 involved healthy participants and was comprised of one period. Single dose of 1.6mg LY3202626 given PO in Period 1. Dose determined by Part A.

干预措施: LY3202626 (Drug)

Part B Cohort 5: 10mg

Experimental

Part B Cohort 5 involved healthy participants and was comprised of one period. Single dose of 10mg LY3202626 given PO in Period 1. Dose determined by Part A.

干预措施: LY3202626 (Drug)

Part B Cohort 6: 26mg

Experimental

Part B Cohort 6 involved healthy participants and was comprised of one period. Single dose of 26mg LY3202626 given PO in Period 1. Dose determined by Part A.

干预措施: LY3202626 (Drug)

Part B Cohort 4, 5, 6: Placebo Comparator

Placebo Comparator

Part B Cohort 4,5,6 involved healthy participants and was comprised of one period. Single dose of PBO given PO in Period 1.

干预措施: Placebo (Part A, B, C) (Drug)

Part C Cohort 7: 1mg

Experimental

Part C Cohort 7 involved healthy participants and was comprised of one period. 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.

干预措施: LY3202626 (Drug)

Part C Cohort 8: 6mg

Experimental

Part C Cohort 8 involved healthy participants and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B.

干预措施: LY3202626 (Drug)

Part C Cohort 9: 26mg

Experimental

Part C Cohort 9 included healthy participants and was comprised of one period. 26mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B.

干预措施: LY3202626 (Drug)

Part C Cohort 7, 8 ,9: Placebo Comparator

Placebo Comparator

Part C Cohort 7,8,9 involved healthy participants and was comprised of one period. Placebo given PO once daily for 14 days.

干预措施: Placebo (Part A, B, C) (Drug)

Part D Cohort 10: 6mg

Experimental

Part D Cohort 10 involved participants with Alzheimer's disease and was comprised of one period. 6mg LY3202626 was given PO once daily for 14 days. Dose determined by Part B.

干预措施: LY3202626 (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 to Study Completion (up to 14 weeks)

A summary of other nonserious Adverse Events (AE's), and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

次要结局

  • PK: Area Under the Concentration Time Curve (AUC) of LY3202626(Part A and B Day 1: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Presdose, 0.5,1, 2, 4, 6, 8,12 hours postdose; Day 14: Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose)
  • PD Biomarker: Cerebral Spinal Fluid (CSF) Minimum Amyloid-beta Peptide (A-beta) 1-40 Concentration(Part B: -4, -2, Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, and 36 hours postdose)
  • Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626(Part A and B Day 1:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose; Part C Day 1:Predose, 0.5,1, 2, 4, 6, 8, and 12 hours postdose; Part C Day 14:Predose, 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 216 hours postdose)
  • PK: CSF Concentration of LY3202626(Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose)
  • Pharmacodynamic(PD) Biomarker: Plasma Minimum Amyloid-Beta Peptide (A-beta) 1-40 Concentration(Part A Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 postdose; Part C Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 120, 168, and 216 postdose)
  • PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration(Parts C: Baseline, Day 15)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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