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LY3127760

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Jun 7, 2019

LY3127760 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

LY3127760 clinical trials

LY3127760 · 1 trial · 1 indication

Phase 1 1
NCT01968070A Study of LY3127760 in Healthy ParticipantsHealthy Volunteers
COMPLETED80 Analytics
PHASE1COMPLETED
A Study of LY3127760 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to Study Completion (Up To Day 42)

Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3127760 (Single)EXPERIMENTALSingle oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.
Placebo (Single)PLACEBO_COMPARATORSingle oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.
LY3127760 (Multiple)EXPERIMENTALMultiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days.
Placebo (Multiple)PLACEBO_COMPARATORMultiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.
Celecoxib (Multiple)ACTIVE_COMPARATORMultiple oral doses of 400 mg celecoxib administered QD for 28 days.

Interventions

NameTypeDescription
LY3127760DRUGAdministered orally
CelecoxibDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males or females as determined by medical history and physical examination * Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Female participants not of chil...

Countries:United States
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Frequently asked questions about LY3127760

What is LY3127760?

LY3127760 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who makes LY3127760?

LY3127760 is made and developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound conducted in the United States.

What phase is LY3127760 in?

LY3127760 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.

What clinical trials is LY3127760 in?

LY3127760 has been evaluated in one clinical trial, NCT01968070, titled A Study of LY3127760 in Healthy Participants. The Phase 1 trial enrolled 80 healthy volunteers in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.

What was the design of the LY3127760 Phase 1 trial?

The Phase 1 trial NCT01968070 studied LY3127760 in 80 healthy adult volunteers aged 18 years and older in the United States. It was a randomized, double-blind, placebo-controlled study, and it has been completed. No efficacy results in patients have been reported.