Clinical trial NCT02242903: A Study of LY3079514 in Healthy Participants
Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3079514 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline to Study Completion (Up to 12 Weeks)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
timeFrame: 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
measure: PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
timeFrame: 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
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: