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LY2969822

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Feb 21, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

LY2969822 · 1 trial · 1 indication

Phase 1 1
NCT02018887A Study of LY2969822 in Healthy ParticipantsHealthy Volunteers
COMPLETED99 Analytics
PHASE1COMPLETED
A Study of LY2969822 in Healthy Participants
Healthy Volunteers
NCT0201888799
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Study Endpoints

Primary Endpoints

Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline Through End of Study (up to Week 7)

A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.

Secondary Endpoints

Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747
Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
PK: Area Under the Drug Plasma Concentration Time Curve (Plasma AUC) of Prodrug LY2969822 and Active Metabolite LSN2934747
All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY2969822 (Part A)EXPERIMENTALSingle dose of LY2969822 administered orally in 2 of 3 study periods.
Placebo (Part A)PLACEBO_COMPARATORSingle dose of placebo administered orally in 1 of 3 study periods.
LY2969822 (Part B)EXPERIMENTALLY2969822 administered orally for 14 days.
Placebo (Part B)PLACEBO_COMPARATORPlacebo administered orally for 14 days.
LY2969822 (Part C)EXPERIMENTALLY2969822 administered orally for 14 days.
Placebo (Part C)PLACEBO_COMPARATORPlacebo administered orally for 14 days.

Interventions

NameTypeDescription
LY2969822DRUGCapsules administered orally
PlaceboDRUGCapsules administered orally
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male participants must agree to use a reliable method of birth control in addition to having their partner use another method for the duration of the study and for 3 months after the last dose of LY2969822 * Female participants must not be of child-bearing potential * Particip...

Countries:Singapore
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Frequently asked questions about LY2969822

What is LY2969822 used for?

LY2969822 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated the drug in healthy participants to assess its safety and tolerability.

Who makes LY2969822?

LY2969822 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker LLY. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is LY2969822 in?

LY2969822 is in Phase 1 clinical development. The single trial, NCT02018887, was a Phase 1 study in healthy participants and has been completed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is LY2969822 in?

LY2969822 has one completed clinical trial, NCT02018887, titled "A Study of LY2969822 in Healthy Participants." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 99 healthy adults in Singapore, with a minimum age of 21 years.

Is LY2969822 FDA approved?

LY2969822 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers. No efficacy or approval data are available, and the drug is still in early clinical development.