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A Study of LY3079514 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: LY3079514
Drug: Placebo
Registration Number
NCT02242903
Lead Sponsor
Eli Lilly and Company
Brief Summary

The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Overtly healthy participants as determined by medical history and physical examination
  • To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese
  • Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m^2) and have a minimum body weight of 50 kilograms (kg), inclusive at screening
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
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Exclusion Criteria
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal blood pressure that is considered to be clinically significant, as determined by the investigator
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Have known or ongoing psychiatric disorders
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
LY3079514LY3079514Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion
PlaceboPlaceboSingle dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
Primary Outcome Measures
NameTimeMethod
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline to Study Completion (Up to 12 Weeks)

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.

Secondary Outcome Measures
NameTimeMethod
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85

Trial Locations

Locations (1)

California Clinical Trials Medical Group

🇺🇸

Glendale, California, United States

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