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

Lilly

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease; Healthy Volunteers

Treatments: Drug: LY3202626; Drug: Itraconazole; Drug: Placebo (Part A, B, C)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323334

15562 (Other Identifier)

I7X-EW-LLCA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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94 participants in 17 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (Part A, B, C)

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: Placebo (Part A, B, C)

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: Placebo (Part A, B, C)

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: Placebo (Part A, B, C)

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: Placebo (Part A, B, C)

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: Placebo (Part A, B, C)

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

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

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part B Cohort 4: 1.6mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part B Cohort 5: 10mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part B Cohort 6: 26mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part B Cohort 4, 5, 6: Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Part A, B, C)

Part C Cohort 7: 1mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part C Cohort 8: 6mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part C Cohort 9: 26mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626

Part C Cohort 7, 8 ,9: Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (Part A, B, C)

Part D Cohort 10: 6mg

Experimental group

Description:

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.

Treatment:

Drug: LY3202626