Phase 1 N=48 Randomized Double-blind Basic Science

A Study of LY3079514 in Healthy Participants

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT02242903 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY3079514 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0; 0; 0; 0; 0; 0	—
SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514	55.1; 480; 3150; 16900; 19000; 41300	—
SECONDARY PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514	38500; 402000; 4850000; 1240000; 6470000	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02242903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.