Healthy VolunteersPhase 1NCT02323334

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

A Phase 1 study testing LY3202626 and Itraconazole in people with Healthy Volunteers and Alzheimer Disease, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Alzheimer Disease
What is being tested?: LY3202626 and Itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Feb 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

California Clinical Trials Medical Group
Glendale, California, 91206

Other trials in United States

About this study

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

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
Being tested: LY3202626, Placebo (Part A, B, C), Itraconazole
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3202626Drug
administered orally
Placebo (Part A, B, C)Drug
administered orally
ItraconazoleDrug
administered orally

Study groups in NCT02323334
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: LY3202626

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Study Completion (up to 14 weeks)

Secondary outcomes (6)

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: Parts C: Baseline, Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Feb 2016

First posted23 Dec 2014 (estimated)
Study startDec 2014
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02323334
Sponsor's protocol ID: 15562
Other IDs: I7X-EW-LLCA
Status last verified: Mar 2021
First submitted: 8 Dec 2014
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3202626
ClinicalTrials.gov ID: NCT02323334
Acronym / sponsor ID: 15562
Conditions: Healthy Volunteers, Alzheimer Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 23 Dec 2014 (estimated)
Results: Posted 19 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 17

Arm	Type	Receives
Part A Cohort 1 Sequence1: 0.1mg, 1.6mg, Placcebo; 15mg	Placebo comparator	Drug: LY3202626, Drug: Placebo (Part A, B, C)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.
Part A Cohort 1 Sequence 2: 0.1mg, PBO, 15mg, 15mg	Experimental	Drug: LY3202626, Drug: Placebo (Part A, B, C)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.
Part A Cohort 1 Sequence 3: PBO, 1.6mg, 15mg, Placebo	Experimental	Drug: LY3202626, Drug: Placebo (Part A, B, C)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.
Part A Cohort 2 Sequence 1:0.4mg, 5mg, PBO, 0.4mg/Itraconazole	Experimental	Drug: LY3202626, Drug: Placebo (Part A, B, C)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.
Part A Cohort 2 Sequence 2: 0.4mg, PBO, 45mg. 0.4mg/Itra	Experimental	Drug: LY3202626, Drug: Placebo (Part A, B, C), Drug: ItraconazolePart 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.
Part A Cohort 2 Sequence 3:PBO, 5mg, 45mg,0.4mg/200mg Itra	Experimental	Drug: LY3202626, Drug: Placebo (Part A, B, C), Drug: ItraconazolePart 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.
Part A Cohort 3 Sequence 1: Food Effect Fed/Fasted	Experimental	Drug: LY3202626Part 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.
Part A Cohort 3 Sequence 2: Food Effect Fasted/Fed	Experimental	Drug: LY3202626Part 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.
Part B Cohort 4: 1.6mg	Experimental	Drug: LY3202626Part 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.
Part B Cohort 5: 10mg	Experimental	Drug: LY3202626Part 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.
Part B Cohort 6: 26mg	Experimental	Drug: LY3202626Part 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.
Part B Cohort 4, 5, 6: Placebo Comparator	Placebo comparator	Drug: Placebo (Part A, B, C)Part B Cohort 4,5,6 involved healthy participants and was comprised of one period. Single dose of PBO given PO in Period 1.
Part C Cohort 7: 1mg	Experimental	Drug: LY3202626Part 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.
Part C Cohort 8: 6mg	Experimental	Drug: LY3202626Part 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.
Part C Cohort 9: 26mg	Experimental	Drug: LY3202626Part 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.
Part C Cohort 7, 8 ,9: Placebo Comparator	Placebo comparator	Drug: Placebo (Part A, B, C)Part C Cohort 7,8,9 involved healthy participants and was comprised of one period. Placebo given PO once daily for 14 days.
Part D Cohort 10: 6mg	Experimental	Drug: LY3202626Part 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.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3202626administered orally	Drug	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)administered orally	Drug	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
Itraconazoleadministered orally	Drug	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

Primary outcome

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

6 secondary outcomes

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3202626
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Parts C: Baseline, Day 15

Results and safety

Results posted to the registry on 19 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

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

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

Time frame: Baseline to Study Completion (up to 14 weeks). Count of participants. Unit: Participants

Measure	Part A, B, and C Placebo (PBO) n = 36	Part A 0.1mg LY3202626 n = 8	Part A 0.4mg LY3202626 n = 8	Part A 0.4mg LY3202626 + 200mg Itraconazole n = 12	Part C 1mg LY3202626 QD n = 9	Part A and B 1.6mg LY3202626 n = 13	Part A 5mg LY3202626 n = 8	Part C and D 6mg LY3202626 QD n = 11	Part A, B and C 10mg LY3202626 n = 19	Part A 15mg LY3202626 n = 11	Part B and C 26mg LY3202626 n = 14	Part A 45mg LY3202626 n = 8
Value	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All participants who received at least one dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, B, and C Placebo	0 of 36 (0%)	10 of 36 (27.8%)	Not reported
Part A 0.1mg LY3202626	0 of 8 (0%)	0 of 8 (0%)	Not reported
Part A 0.4mg LY3202626	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Part A 0.4mg LY3202626 + 200mg Itraconazole	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
Part C 1mg LY3202626 QD	0 of 9 (0%)	4 of 9 (44.4%)	Not reported
Part A and B 1.6mg LY3202626	0 of 13 (0%)	4 of 13 (30.8%)	Not reported
Part A 5mg LY3202626	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Part C and Part D 6mg LY3202626 QD	0 of 11 (0%)	6 of 11 (54.5%)	Not reported
Part A and B 10mg LY3202626	0 of 19 (0%)	7 of 19 (36.8%)	Not reported
Part A 15mg LY3202626	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Part B and C 26mg LY3202626	0 of 14 (0%)	13 of 14 (92.9%)	Not reported
Part A 45mg LY3202626	0 of 8 (0%)	1 of 8 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3202626 and Itraconazole in people with Healthy Volunteers and Alzheimer Disease, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Study Completion (up to 14 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02323334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.