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LY3000328

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: May 31, 2012

LY3000328 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

LY3000328 clinical trials

LY3000328 · 1 trial · 1 indication

Phase 1 1
NCT01515358A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy ParticipantsHealthy Volunteers
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of participants with one or more drug related adverse events (AEs) or any serious AEs
Baseline to study completion (estimate 3 months)

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328
Pre-dose up to Day 6 post-dose
Pharmacokinetics: Maximum concentration (Cmax) of LY3000328
Pre-dose up to Day 6 post-dose
Change in Cathepsin S (CatS) activity
Pre-dose, up to 48 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORSingle dose of placebo administered orally in 1 out of 3 study periods separated by at least a 7-day wash-out period between each dose.
LY3000328EXPERIMENTALSingle escalating dose of up to 300 mg/kg of LY3000328 administered orally in 2 out of 3 study periods separated by at least a 7 day wash-out period between each dose.

Interventions

NameTypeDescription
PlaceboDRUGAdministered orally
LY3000328DRUGAdministered orally
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Eligibility Criteria

Age Range35 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination

Countries:Singapore
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Frequently asked questions about LY3000328

What is LY3000328?

LY3000328 is an investigational small molecule being developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing LY3000328?

LY3000328 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly conducted the Phase 1 study of the compound in healthy participants.

What phase is LY3000328 in?

LY3000328 is in Phase 1 development. It has completed one Phase 1 clinical trial, and no later-stage trials have been initiated. It is an investigational drug and has not been approved by the FDA.

What clinical trials is LY3000328 in?

LY3000328 has been evaluated in one completed Phase 1 trial, NCT01515358, titled A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants. The trial enrolled 18 healthy volunteers in Singapore and was randomized, double-blind, and placebo-controlled.

What was the design of the LY3000328 Phase 1 trial?

The Phase 1 trial NCT01515358 evaluated the safety and tolerability of LY3000328 in healthy participants. It was a randomized, double-blind, placebo-controlled study that enrolled 18 participants in Singapore. Participants were 35 years of age or older, and the trial has been completed.