A Study of LY3079514 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3079514 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242903
• Other study ID #: 15190
• Secondary ID: I7B-MC-DPAA
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: February 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY3079514
Administered SC
• LY3079514
Administered IV
• Placebo
Administered SC
• Placebo
Administered IV

Locations

Country	Name	City	State
United States	California Clinical Trials Medical Group	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	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.	Baseline to Study Completion (Up to 12 Weeks)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514		SC 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
Secondary	PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-8) of LY3079514		SC 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