Healthy Volunteers
Conditions
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.
Interventions
DRUGLY3079514
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (Up to 12 Weeks) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion. | 12 |
| LY3079514 (LY) Cohort 1 7 mg single dose of LY3079514 administered by SC injection during a single occasion | 6 |
| LY Cohort 2 21 mg single dose of LY3079514 administered by SC injection during a single occasion | 6 |
| LY Cohort 3 70 mg single dose of LY3079514 administered by SC during a single occasion | 6 |
| LY Cohort 4 210 mg single dose of LY3079514 administered by SC during a single occasion | 6 |
| LY Cohort 5 70 mg single dose of LY3079514 administered IV during a single occasion | 6 |
| LY Cohort 6 210 mg single dose of LY3079514 administered IV during a single occasion | 6 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | LY Cohort 5 | LY Cohort 6 | Total | Placebo | LY3079514 (LY) Cohort 1 | LY Cohort 2 | LY Cohort 3 | LY Cohort 4 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 11.56 | 49.3 years STANDARD_DEVIATION 5.61 | 40.5 years STANDARD_DEVIATION 11.65 | 41.1 years STANDARD_DEVIATION 11.96 | 35.5 years STANDARD_DEVIATION 10.82 | 34.5 years STANDARD_DEVIATION 12.42 | 38.0 years STANDARD_DEVIATION 12.82 | 45.3 years STANDARD_DEVIATION 12.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 6 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 42 Participants | 11 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Japanese | 0 participants | 3 participants | 12 participants | 3 participants | 0 participants | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Non-Japanese | 6 participants | 3 participants | 36 participants | 9 participants | 6 participants | 3 participants | 6 participants | 3 participants |
| Region of Enrollment United States | 6 participants | 6 participants | 48 participants | 12 participants | 6 participants | 6 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 12 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 36 Participants | 8 Participants | 5 Participants | 5 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 4 / 6 | 1 / 6 | 3 / 6 | 4 / 6 | 3 / 6 | 4 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: Baseline to Study Completion (Up to 12 Weeks)
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| LY3079514 (LY) Cohort 1 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| LY Cohort 2 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| LY Cohort 3 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| LY Cohort 4 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| LY Cohort 5 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| LY Cohort 6 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
Time frame: 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
Population: All randomized participants who received at least 1 dose of study drug and had evaluable Cmax PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | 55.1 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 93 |
| LY3079514 (LY) Cohort 1 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | 480 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 64 |
| LY Cohort 2 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | 3150 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 118 |
| LY Cohort 3 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | 16900 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 45 |
| LY Cohort 4 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | 19000 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 13 |
| LY Cohort 5 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514 | 41300 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22 |
Secondary
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
Time frame: 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
Population: All randomized participants who received at least 1 dose of investigational drug and had evaluable AUC PK data. Cohort 1 had zero participants analyzed and was not included in summary statistics.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY3079514 (LY) Cohort 1 | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 | 38500 nanogram•hour/milliliter (ng•h/mL) | Geometric Coefficient of Variation 59 |
| LY Cohort 2 | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 | 402000 nanogram•hour/milliliter (ng•h/mL) | Geometric Coefficient of Variation 80 |
| LY Cohort 3 | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 | 4850000 nanogram•hour/milliliter (ng•h/mL) | Geometric Coefficient of Variation 37 |
| LY Cohort 4 | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 | 1240000 nanogram•hour/milliliter (ng•h/mL) | Geometric Coefficient of Variation 20 |
| LY Cohort 5 | PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514 | 6470000 nanogram•hour/milliliter (ng•h/mL) | Geometric Coefficient of Variation 14 |