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Drug

Phase 1

Healthy Male Volunteers | Unknown | Other |Eli Lilly and Company|Last Updated: Jul 3, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

Drug · 1 trial · 1 indication

Phase 1 1
NCT01577355A Study of LY2784544 in Healthy Male SubjectsHealthy Male Volunteers
COMPLETED8 Analytics
PHASE1COMPLETED
A Study of LY2784544 in Healthy Male Subjects
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Study Endpoints

Primary Endpoints

Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered
Predose up to 14 days post dose

Secondary Endpoints

Plasma pharmacokinetics of LY2784544 and radioactivity maximum observed concentration (Cmax)
Predose up to 14 days post dose
Plasma pharmacokinetics of LY27854544 and radioactivity time of maximum observed concentration (tmax)
Predose up to 14 days post dose
Plasma pharmacokinetics of LY2784544 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast)
Predose up to 14 days post dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
[C14]-LY2784544EXPERIMENTALSingle 30 mg oral dose containing 100 micro curies of LY2784544

Interventions

NameTypeDescription
DrugRADIATIONSingle 30 mg oral dose containing 100 micro curies of LY2784544
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males as determined by medical history and physical examination * Will either be sterile or, if sexually active, agree to use a reliable method of birth control from the day before dosing until 3 months after the end of the study * Have a body mass index (BM...

Countries:United States
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Frequently asked questions about Drug

What is Drug used for?

Drug is an investigational therapy being studied in healthy male volunteers. It is currently in Phase 1 clinical development, with a completed trial that enrolled 8 participants in the United States. The drug is not approved for any indication and remains under investigation.

Who makes Drug?

Drug is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational drug, which is currently in Phase 1 development.

What phase is Drug in?

Drug is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 8 healthy male volunteers in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Drug in?

Drug has one completed clinical trial, identified as NCT01577355, titled "A Study of LY2784544 in Healthy Male Subjects." This Phase 1 study enrolled 8 healthy male volunteers aged 18 years and older in the United States.

Is Drug FDA approved?

Drug is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy volunteers is part of early-stage research, and the drug has not received marketing approval.