A Study of LY3079514 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LY3079514

Study type: Interventional

Funder types: Industry

Identifiers

NCT02242903

I7B-MC-DPAA (Other Identifier)

15190

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

48 participants in 2 patient groups, including a placebo group

LY3079514

Experimental group

Description:

Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion

Treatment:

Drug: LY3079514

Drug: LY3079514

Placebo

Placebo Comparator group

Description:

Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.

Treatment:

Drug: Placebo

Drug: Placebo