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

NCT02323334 | Completed Phase 1 Results

• 2 other identifiers: 15562I7X-EW-LLCA
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

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

  Baseline to Study Completion (up to 14 weeks)

Secondary Outcomes (6)

• 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: 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

• 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: 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

• PK: CSF Concentration of LY3202626

  Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose

Study Arms (17)

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Drug: LY3202626

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.

Drug: LY3202626

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.

Drug: LY3202626

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.

Drug: LY3202626

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.

Drug: LY3202626

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.

Drug: Placebo (Part A, B, C)

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.

Drug: LY3202626

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.

Drug: LY3202626

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.

Drug: LY3202626

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.

Drug: Placebo (Part A, B, C)

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.

Drug: LY3202626

Interventions

LY3202626 DRUG

administered orally

Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg; Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo; Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg; Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole; Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra; Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra; Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted; Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed; Part B Cohort 4: 1.6mg; Part B Cohort 5: 10mg; Part B Cohort 6: 26mg; Part C Cohort 7: 1mg; Part C Cohort 8: 6mg; Part C Cohort 9: 26mg; Part D Cohort 10: 6mg

Placebo (Part A, B, C) DRUG

administered orally

Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg; Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo; Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg; Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole; Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra; Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra; Part B Cohort 4, 5, 6: Placebo Comparator; Part C Cohort 7, 8 ,9: Placebo Comparator

Itraconazole DRUG

administered orally

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

LY3202626; Itraconazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 19, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-03

Locations

US (1)