Recent Updates
Recently added Catalysts

LY3031207

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Jul 5, 2019

LY3031207 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

LY3031207 clinical trials

LY3031207 · 1 trial · 1 indication

Phase 1 1
NCT01449630A Study of LY3031207 in Healthy SubjectsHealthy Volunteers
COMPLETED29 Analytics
PHASE1COMPLETED
A Study of LY3031207 in Healthy Subjects
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE
Baseline, up to 4 months

AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.

Secondary Endpoints

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3031207
Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose
Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207
Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose
Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation
Predose, 0.5, 1, 2, 8, 24 and 144 hours post dose.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3031207EXPERIMENTALParticipants received escalating doses of 5 mg (milligrams), 25 mg, 75 mg, 225 mg, 450 mg and 900 mg of LY3031207 capsule orally.
PlaceboPLACEBO_COMPARATORSingle dose of placebo administered orally in up to two occasions separated by at least a 3 week wash-out period between each dose.
CelecoxibACTIVE_COMPARATORSingle 400mg dose of celecoxib administered orally on one occasion.

Interventions

NameTypeDescription
LY3031207DRUGAdministered orally
PlaceboDRUGAdministered orally
CelecoxibDRUGAdministered orally
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male subjects agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product * Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy w...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about LY3031207

What is LY3031207?

LY3031207 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. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early clinical development.

Who makes LY3031207?

LY3031207 is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the developer and sponsor of the compound's clinical program.

What phase is LY3031207 in?

LY3031207 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program's only listed trial, NCT01449630, has been completed, and no active trials are currently listed for this compound.

What clinical trials is LY3031207 in?

LY3031207 has been evaluated in one clinical trial, NCT01449630, titled A Study of LY3031207 in Healthy Subjects. The Phase 1 trial was completed in the United States and enrolled 29 healthy adult volunteers. It was randomized, double-blind, and placebo-controlled.

What was the design of the LY3031207 Phase 1 trial?

The Phase 1 trial of LY3031207, NCT01449630, was a randomized, double-blind, placebo-controlled study conducted in the United States. It enrolled 29 healthy volunteers aged 18 years and older, with both sexes eligible. The study has been completed.