A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease

NCT ID: NCT02323334

Last Updated: 2021-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-02-29

Brief Summary

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.

Conditions

Healthy Volunteers; Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: PLACEBO_COMPARATOR

LY3202626

Intervention Type: DRUG

administered orally

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

Itraconazole

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

Itraconazole

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

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

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part B Cohort 4: 1.6mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part B Cohort 5: 10mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part B Cohort 6: 26mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part B Cohort 4, 5, 6: 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.

Group Type: PLACEBO_COMPARATOR

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

Part C Cohort 7: 1mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part C Cohort 8: 6mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part C Cohort 9: 26mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Part C Cohort 7, 8 ,9: 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.

Group Type: PLACEBO_COMPARATOR

Placebo (Part A, B, C)

Intervention Type: DRUG

administered orally

Part D Cohort 10: 6mg

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.

Group Type: EXPERIMENTAL

LY3202626

Intervention Type: DRUG

administered orally

Interventions

LY3202626

administered orally

Intervention Type: DRUG

Placebo (Part A, B, C)

administered orally

Intervention Type: DRUG

Itraconazole

administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

California Clinical Trials Medical Group

Glendale, California, United States

Countries

United States

Other Identifiers

I7X-EW-LLCA

Identifier Type: OTHER

Identifier Source: secondary_id

15562

Identifier Type: -

Identifier Source: org_study_id