A Study of LY3202626 in Healthy Participants and Particip... | NCT02323334 | Trialant
NCT02323334
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 19, 2021Actual
Enrollment
94Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Alzheimer Disease
Interventions
LY3202626
Placebo (Part A, B, C)
Itraconazole
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02323334
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15562
Secondary IDs
ID
Type
Description
Link
I7X-EW-LLCA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
Official Title
Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2014
Primary Completion Date
Feb 2016Actual
Completion Date
Feb 2016Actual
First Submitted Date
Dec 8, 2014
First Submission Date that Met QC Criteria
Dec 17, 2014
First Posted Date
Dec 23, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 22, 2021
Results First Submitted that Met QC Criteria
Mar 22, 2021
Results First Posted Date
Apr 19, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 22, 2021
Last Update Posted Date
Apr 19, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy Volunteers
Alzheimer Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
94Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
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
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626
Summary of PK parameters of LY3202626 in plasma following oral administration of single doses for Parts A and B and multiple doses for Part C.
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
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
California Clinical Trials Medical Group
Glendale
California
91206
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Cohort 1 Sequence 1: 0.1mg, 1.6mg, Placebo (PBO); 15mg
Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses.
Period 1: 0.1mg LY3202626 Period 2: 1.6mg LY3202626 Period 3: 15 mg PBO Period 4: 15mg LY3202626
FG001
Part A Cohort 1 Sequence 2: 1.6mg, PBO,15mg, 15mg
Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses.
Period 1: 1.6mg LY3202626 Period 2: PBO Period 3: 15mg LY3202626 Period 4: 15mg LY3202626
FG002
Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, PBO
Part A Cohort 1 involved healthy participants and was comprised of 4 treatment periods. There was a washout period of approximately 14 days between doses.
Period 1: PBO Period 2: 1.6mg LY3202626 Period 3: 15mg LY3202626 Period 4: PBO
FG003
Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO; 0.4mg/200mg Itra
Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole (Itra). There was 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
FG004
Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/200mg Itra
Part A Cohort 2 involved healthy participants and was comprised of 4 treatment periods. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole.There was 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
FG005
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. Period 4 includes 0.4mg LY3202626 and 200mg Itraconazole. There was 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
FG006
Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted
Part A Cohort 3 involved healthy participants and was comprised of two treatment periods. Single dose of 10mg LY3202626 given PO in Period 1 and 2. There was a washout period of approximately 14 days between doses.
Period 1: Fed Period 2: Fasted
FG007
Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed
Part A Cohort 3 involved healthy participants and was comprised of two treatment periods. Single dose 10mg LY3202626 given PO in Period 1 and 2.
There was a washout period of approximately 14 days between doses.
Period 1: Fasted Period 2: Fed
FG008
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.
FG009
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.
FG010
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.
FG011
Part B Cohort 4, 5, 6: PBO 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.
FG012
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.
FG013
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.
FG014
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.
FG015
Part C Cohort 7, 8 ,9: PBO Comparator
Part C Cohort 7, 8, 9 involved healthy participants and was comprised of one period. PBO given PO once daily for 14 days.
FG016
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.
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0085 subjects
FG0097 subjects
FG0105 subjects
FG0113 subjects
FG0129 subjects
FG0139 subjects
FG0149 subjects
FG0159 subjects
FG0162 subjects
Received at Least One Dose of Study Drug
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
COMPLETED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Period 2
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG003
Period 3
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG003
Period 4
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Cohort 1
Escalating single dose given orally (PO)per randomly assigned treatment sequence of 0.1mg, 1.6mg, 15mg LY3202626 or placebo.
BG001
Part A Cohort 2
Escalating single dose given PO per randomly assigned treatment sequence of 0.4mg, 5mg, or 45mg LY3202626, placebo.
Some participants may also receive multiple doses of 200 mg of Itraconazole PO in 1 period with 0.4mg of LY3202626.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
All participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
No
Baseline to Study Completion (up to 14 weeks)
ID
Title
Description
OG000
Part A, B, and C Placebo (PBO)
Single dose placebo given PO in Part A and B. Multiple doses of PBO given PO in Part C.
OG001
Part A 0.1mg LY3202626
Single dose of 0.1mg LY3202626 given PO Period 1 Cohort 1.
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A, B, and C Placebo
Single dose of placebo given PO in in capsule form, Part A and B. Multiple doses of placebo given PO in capsule form, Part C.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Postural orthostatic tachycardia syndrome
Cardiac disorders
MedDRA 17.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D000544
Alzheimer Disease
Ancestor Terms
ID
Term
D003704
Dementia
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000719000
LY3202626
D017964
Itraconazole
Ancestor Terms
ID
Term
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
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
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
PK: Area Under the Concentration Time Curve (AUC) of LY3202626
Pharmacokinetic parameters for Part A and B were assessed on Day 1 using AUC 0-infinity (AUC0-inf). Pharmacokinetic parameters for Part C were assessed on Day 1 using AUC zero to time to last (AUC0-tlast), Day 14 using AUC steady state.
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
Plasma minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of plasma A-beta 1-40 following dose administration.
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
CSF minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of CSF A-beta 1-40 following dose administration.
Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose
PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration
CSF Aβ1-40 change from baseline at Day 15 endpoint, 24 hours postdose (+/- 4 hours) following multiple doses of LY3202626.
Parts C: Baseline, Day 15
FG004
4 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0085 subjects
FG0097 subjects
FG0105 subjects
FG0113 subjects
FG0129 subjects
FG0139 subjects
FG0149 subjects
FG0159 subjects
FG0162 subjects
4 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0085 subjects
FG0097 subjects
FG0105 subjects
FG0113 subjects
FG0129 subjects
FG0139 subjects
FG0149 subjects
FG0159 subjects
FG0162 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
4 subjects
FG0044 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0080 subjectsPart B was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0090 subjectsPart B was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0100 subjectsPart B was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0110 subjectsPart B was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0120 subjectsPart C was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0130 subjectsPart C was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0140 subjectsPart C was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0150 subjectsPart C was a single period conducted in parallel to Part A and received last dose in Period 1.
FG0160 subjectsPart D was a single period conducted in parallel to Part A and received last dose in Period 1.
COMPLETED
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0066 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
4 subjects
FG0044 subjects
FG0054 subjects
FG0060 subjectsPart A Cohort 3 Food Effect participated in Period 1 and Period 2 only.
FG0070 subjectsPart A Cohort 3 Food Effect participated in Period 1 and Period 2 only.
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
4 subjects
FG0044 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
COMPLETED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
BG002
Part A Food Effect Cohort 3
Single dose of 10mg LY3202626 given PO in Period 1 and Period 2 only.
BG003
Part B Cohort 4
Single oral dose of 1.6mg LY3202626 or placebo given PO in Period 1. Dose determined by Part A.
BG004
Part B Cohort 5
Single oral dose of 10mg LY3202626 or placebo given PO in in Period 1. Dose determined by Part A.
BG005
Part B Cohort 6
Single oral dose of 26mg LY3202626 or placebo given PO in Period 1. Dose determined by Part A.
BG006
Part C Cohort 7
Multiple oral doses of 1mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
BG007
Part C Cohort 8
Multiple oral doses of 6mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
BG008
Part C Cohort 9
Multiple oral doses of 26mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
BG009
Part D Cohort 10
Multiple oral doses of 6mg LY3202626 given PO once daily for 14 days. Dose determined by Part B.
BG010
Total
Total of all reporting groups
12
BG00112
BG00212
BG0036
BG0048
BG0056
BG00612
BG00712
BG00812
BG0092
BG01094
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00033.0± 8.1
BG00136.9± 8.4
BG00239.0± 13.6
BG00336.5± 12.4
BG00443.0± 11.3
BG00535.2± 7.2
BG00637.5± 10.5
BG00740.4± 8.1
BG00840.5± 10.5
BG00968.0± 2.8
BG01038.70± 10.93
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG0024
BG0030
BG0040
BG0050
BG0060
BG0071
BG0081
BG0092
BG01010
Male
BG00011
BG00111
BG0028
BG0036
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG0023
BG0030
BG0041
BG0053
BG0062
BG0073
BG0083
BG0090
BG01018
Not Hispanic or Latino
BG00010
BG00111
BG0029
BG0036
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Asian
BG0006
BG0016
BG0024
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0002
BG0012
BG0023
BG0032
BG004
White
BG0003
BG0014
BG0025
BG0034
BG004
More than one race
BG0001
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00012
BG00112
BG00212
BG0036
BG0048
BG0056
BG00612
BG00712
BG00812
BG0092
BG01094
OG002
Part A 0.4mg LY3202626
Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2.
OG003
Part A 0.4mg LY3202626 + 200mg Itraconazole
Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in Period 4 Cohort 2.
OG004
Part C 1mg LY3202626 QD
Multiple daily dose of 1mg LY3202626 given PO once daily for 14 days.
OG005
Part A and B 1.6mg LY3202626
Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1 in Part A and Period 1 Part B.
OG006
Part A 5mg LY3202626
Single dose of 5mg LY3202626 given PO in in Period 2 Cohort 2.
OG007
Part C and D 6mg LY3202626 QD
Multiple daily dose of 6mg LY3202626 given PO once daily for 14 days.
OG008
Part A, B and C 10mg LY3202626
Single dose of 10mg LY3202626 given PO in Part A and B. Multiple dose of 10mg LY3202626 given PO in Part C once daily for 14 days.
OG009
Part A 15mg LY3202626
Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1.
OG010
Part B and C 26mg LY3202626
Single dose of 26mg LY3202626 given PO in Period 1 in Part B. Multiple daily dose of 26mg LY3202626 given PO once daily for 14 days in Part C.
OG011
Part A 45mg LY3202626
Single dose of 45mg LY3202626 given PO in in Period 3 Cohort 2.
Units
Counts
Participants
OG00036
OG0018
OG0028
OG00312
OG0049
OG00513
OG0068
OG00711
OG00819
OG00911
OG01014
OG0118
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Secondary
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626
Summary of PK parameters of LY3202626 in plasma following oral administration of single doses for Parts A and B and multiple doses for Part C.
All participants in Part A, B, and C who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
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
ID
Title
Description
OG000
Part A 0.1mg LY3202626
Single dose of 0.1mg LY3202626 given PO in Period 1 Cohort 1.
OG001
Part A 0.4mg LY3202626
Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2.
OG002
Part A 1.6mg LY3202626
Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1.
OG003
Part A 5mg LY3202626
Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2.
OG004
Part A 15mg LY3202626
Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1.
OG005
Part A 45mg LY3202626
Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2.
OG006
Part B 1.6mg LY3202626
Single dose of 1.6mg LY3202626 given PO Period 1.
OG007
Part B 10mg LY3202626
Single dose of 10mg LY3202626 given PO in Period 1.
OG008
Part B 26mg LY3202626
Single dose of 26mg LY3202626 given PO in Period1.
OG009
Part C 1mg LY3202626 QD
Multiple doses of 1mg LY3202626 given PO once daily for 14 days.
OG010
Part C 6mg LY3202626 QD
Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
OG011
Part C 26mg LY3202626 QD
Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
Units
Counts
Participants
OG0003
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.169± 50
OG0010.486± 81
OG0022.89± 70
OG003
Secondary
PK: Area Under the Concentration Time Curve (AUC) of LY3202626
Pharmacokinetic parameters for Part A and B were assessed on Day 1 using AUC 0-infinity (AUC0-inf). Pharmacokinetic parameters for Part C were assessed on Day 1 using AUC zero to time to last (AUC0-tlast), Day 14 using AUC steady state.
All participants in Parts A, B, and C who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram x hour/milliliter (ng*hr/mL)
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
ID
Title
Description
OG000
Part A 0.1mg LY3202626
Single dose of 0.1mg LY3202626 given PO in Period 1 Cohort 1.
OG001
Part A 0.4mg LY3202626
Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2.
OG002
Part A 1.6mg LY3202626
Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1.
OG003
Part A 5mg LY3202626
Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2.
OG004
Part A 15mg LY3202626
Single dose of 15mg LY3202626 given PO in Period 3 Cohort 1.
OG005
Part A 45mg LY3202626
Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2.
OG006
Part B 1.6mg LY3202626
Single dose of 1.6mg LY3202626 given PO in Period 1.
OG007
Part B 10mg LY3202626
Single dose of 10mg LY3202626 given PO in Period 1.
OG008
Part B 26mg LY3202626
Single dose of 26mg LY3202626 given PO in Period 1.
OG009
Part C 1mg LY3202626 QD
Multiple doses of 1mg LY3202626 given PO once daily for 14 days..
OG010
Part C 6mg LY3202626 QD
Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
OG011
Part C 26mg LY3202626 QD
Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
Units
Counts
Participants
OG0003
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAAt doses less than 1.6 mg, the AUC(0-∞) could not be reliably quantified.
OG001NA± NAAt doses less than 1.6 mg, the AUC(0-∞) could not be reliably quantified.
Plasma minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of plasma A-beta 1-40 following dose administration.
All participants in Part A, Periods 1-3 and Part C, Period 3, who received at least one dose of study drug and had evaluable PD data analyzed per protocol. Participants in Part B and D were not assessed per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
Picogram per milliliter (pg/mL)
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
ID
Title
Description
OG000
Part A Placebo
Single dose of placebo given PO in capsule form in Period 1-4.
OG001
Part A 0.1mg LY3202626
Single dose 0.1mg LY3202626 given PO in Period 1 Cohort 1.
OG002
Part A 0.4mg LY3202626
Single dose of 0.4mg LY3202626 given PO in Period 1 Cohort 2.
OG003
Part A 1.6 mg LY3202626
Single dose of 1.6mg LY3202626 given PO in Period 2 Cohort 1.
OG004
Part A 5mg LY3202626
Single dose of 5mg LY3202626 given PO in Period 2 Cohort 2.
OG005
Part A 15mg LY3202626
Single dose of 15mg LY3202626 given PO in Period 3 and Period 4 Cohort 1.
OG006
Part A 45mg LY3202626
Single dose of 45mg LY3202626 given PO in Period 3 Cohort 2.
OG007
Part C Placebo
Multiple doses of placebo given PO once daily for 14 days.
OG008
Part C 1mg LY3202626 QD
Multiple doses of 1mg LY3202626 in given PO once daily for 14 days.
OG009
Part C 6mg LY3202626 QD
Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
OG010
Part C 26mg LY3202626 QD
Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
CSF minimum A-beta 1-40 concentration or nadir concentration (Cnadir) is defined as the lowest concentration of CSF A-beta 1-40 following dose administration.
All participants in Part B who received at least one dose of study drug and had evaluable CSF PD data analyzed per protocol. Participants in Part A, C and D were not assessed per protocol.
Single dose of 1.6mg LY3202626 given PO in Period 1.
OG002
Part B 6mg LY3202626
Single dose of 6mg LY3202626 given PO in Period 1.
OG003
Part B 26mg LY3202626
Single dose of 26mg LY3202626 given PO in Period 1.
Units
Counts
Participants
OG0003
OG0015
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0007980± 53.8
OG0015700± 22.3
OG0025770± 41.8
OG003
Secondary
PK: CSF Concentration of LY3202626
All participants in Part C who received at least one dose of study drug and had evaluable CSF PK data per protocol. Participants in Part A, B and D were not assessed per protocol.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Part C: Day 15 at 24 hours +/- 4 hours (hr) postdose
ID
Title
Description
OG000
Part C 1mg LY3202626
Multiple doses of 1mg LY3202626 given PO once daily for 14 days.
OG001
Part C 6 mg LY3202626
Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
OG002
Part C 26mg LY3202626
Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
Units
Counts
Participants
OG0009
OG0019
OG0029
Title
Denominators
Categories
Title
Measurements
OG0000.0648± 46.2
OG0010.202± 48.9
OG0021.26± 44.8
Secondary
PD Biomarker: Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid-beta Peptide (A-beta) 1-40 Concentration
CSF Aβ1-40 change from baseline at Day 15 endpoint, 24 hours postdose (+/- 4 hours) following multiple doses of LY3202626.
All participants in Part C who received at least one dose of study drug and had evaluable CSF PD data analyzed. Participants in Part A, B and D were not assessed per protocol.
Posted
Mean
Standard Deviation
percent change in concentration
Parts C: Baseline, Day 15
ID
Title
Description
OG000
Part C Placebo
Multiple doses of placebo given PO once daily for 14 days.
OG001
Part C 1mg LY3202626
Multiple doses of 1mg LY3202626 given PO once daily for 14 days.
OG002
Part C 6mg LY3202626
Multiple doses of 6mg LY3202626 given PO once daily for 14 days.
OG003
Part C 26mg LY3202626
Multiple doses of 26mg LY3202626 given PO once daily for 14 days.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.3± 16.8
OG001-50.1± 8.56
OG002-75.7± 7.38
OG003
0
36
10
36
EG001
Part A 0.1mg LY3202626
Single dose of 0.1mg LY3202626 given PO in in capsule form.
0
8
0
8
EG002
Part A 0.4mg LY3202626
Single dose of 0.4mg LY3202626 given PO in in capsule form.
0
8
1
8
EG003
Part A 0.4mg LY3202626 + 200mg Itraconazole
Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in in capsule form.
0
12
7
12
EG004
Part C 1mg LY3202626 QD
Multiple daily dose of 1mg LY3202626 given PO in in capsule form.
0
9
4
9
EG005
Part A and B 1.6mg LY3202626
Single dose of 1.6mg LY3202626 given PO in in capsule form..
0
13
4
13
EG006
Part A 5mg LY3202626
Single dose of 5mg LY3202626 given PO in in capsule form.
0
8
3
8
EG007
Part C and Part D 6mg LY3202626 QD
Multiple daily dose of 6mg LY3202626 given PO in capsule form.
0
11
6
11
EG008
Part A and B 10mg LY3202626
Single dose of 10mg LY3202626 given PO in capsule form.
0
19
7
19
EG009
Part A 15mg LY3202626
Single dose of 15mg LY3202626 given PO in capsule form.
0
11
2
11
EG010
Part B and C 26mg LY3202626
Single dose of 26mg LY3202626 given PO in capsule form, Part B. Multiple daily dose of 26mg LY3202626 in in capsule form, Part C.
0
14
13
14
EG011
Part A 45mg LY3202626
Single dose of 45mg LY3202626 given PO in in capsule form.