NCT02242903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2014

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

October 4, 2018

Completed
Last Updated

October 4, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

September 15, 2014

Results QC Date

February 18, 2018

Last Update Submit

February 18, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) 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

Study Arms (2)

LY3079514

EXPERIMENTAL

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

Drug: LY3079514

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY3079514DRUG

Administered SC

LY3079514
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 4, 2018

Results First Posted

October 4, 2018

Record last verified: 2018-02

Locations

US(1)