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LY3050258

Phase 1

Healthy Participants | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

LY3050258 · 2 trials · 2 indications

Phase 1 2
NCT02121834A Study of LY3050258 in Healthy ParticipantsHealthy Volunteers
COMPLETED63 Analytics
NCT01929707A Study of LY3050258 in Healthy ParticipantsHealthy Participants
COMPLETED38 Analytics
PHASE1COMPLETED
A Study of LY3050258 in Healthy Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study of LY3050258 in Healthy Participants
Healthy ParticipantsUnlock 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 14 Weeks)

Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258
Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258
Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258
Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3050258EXPERIMENTALDaily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg.
PlaceboPLACEBO_COMPARATORDaily dose of placebo matching LY3050258 for 28 days.

Interventions

NameTypeDescription
LY3050258DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or healthy postmenopausal females, including Japanese participants * Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m\^2), inclusive Exclusion Criteria: * Abnormal siting blood pressure as determined by the investigator * Abnormality in the 1...

Countries:United States
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Frequently asked questions about LY3050258

What is LY3050258 used for?

LY3050258 is an investigational small molecule being studied in healthy participants and healthy volunteers. It is in Phase 1 clinical development, with completed trials evaluating its effects in these populations. The drug is not approved and remains under investigation.

Who makes LY3050258?

LY3050258 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy participants.

What phase is LY3050258 in?

LY3050258 is in Phase 1 clinical development. It is an investigational small molecule, and its trials in healthy participants and healthy volunteers have been completed. The drug is not FDA approved and is still under clinical investigation.

What clinical trials is LY3050258 in?

LY3050258 has been studied in two completed Phase 1 clinical trials: NCT01929707 and NCT02121834, both titled 'A Study of LY3050258 in Healthy Participants.' These trials enrolled healthy participants and healthy volunteers in the United States, with a minimum age of 30 years.

Is LY3050258 the same as any other drug?

LY3050258 is the primary name for this investigational small molecule developed by Eli Lilly and Company. No alternative names have been associated with this drug in the available clinical trial information.