Kidney Failure, Chronic
Conditions
Keywords
Renal dialysis
Brief summary
The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.
Interventions
DRUGLY3113593
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy Participants: * Healthy males or females * Participants have a body mass index (BMI) of 18.5 to 29.9 kilogram per meter square (kg/m\^2), inclusive at screening * Participants Treated with Hemodialysis: * Participants are males or females who have end-stage renal disease (ESRD) and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening * Participants have a hemoglobin value greater than or equal to (≥)9.0 grams per deciliter (g/dL) and less than or equal to (≤)12.5 g/dL at screening * Participants have a body mass index (BMI) of 18.5 to 45.0 kg/m\^2, inclusive, at screening * Both Populations: * Male participants agree to use a reliable method of birth control and avoid donating sperm during the study and for 3 months following the dose of the investigational product * Female participants must not be of child-bearing potential
Exclusion criteria
* Healthy Participants: * Participants that 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 * Participants that have used or intend to use over-the-counter or prescription medication, including herbal medications within 14 days prior to dosing * Participants Treated with Hemodialysis: * Participants that have a history of myocardial infarction, acute coronary syndrome, stroke or transient ischemic attacks within the prior 6 months * Participants that have heart failure that results in dyspnea at rest or during minimal exercise * Participants that have poorly controlled hypertension * Participants that have a history of significant thrombotic disease, pulmonary hypertension, significant hematological disease or current liver disease, known hepatic or biliary abnormalities * Participants that had a blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study * Participants that have evidence of active peptic, duodenal, or esophageal ulcer disease or gastrointestinal bleeding within the prior 12 weeks * Both Populations: * Participants that have known allergies to related compounds or any components of the study drug or its formulation, clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions or history of significant atopy * Participants that have participated, within the last 30 days (or 5 half-lives if long half life) in a clinical trial involving an investigational product * Participants that have known or ongoing psychiatric disorders
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 through end of study (Day 85) | The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85 |
| Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios | Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85 |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85 |
| Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | Baseline, Day 85 |
| Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | Baseline, Day 85 |
| Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | Baseline, Day 85 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Part A) Single dose of placebo matching LY3113593. | 14 |
| LY IV 1.5mg (Part A) Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg). | 6 |
| LY IV 5mg (Part A) Single dose of LY3113593 administered intravenous (IV) at 5 mg. | 6 |
| LY IV 15mg (Part A) Single dose of LY3113593 administered IV at 15 mg. | 6 |
| LY IV 50mg (Part A) Single dose of LY3113593 administered IV at 50 mg. | 6 |
| LY IV 150mg (Part A) Single dose of LY3113593 administered IV at 150 mg. | 6 |
| LY IV 400mg (Part A) Single dose of LY3113593 administered IV at 400 mg. | 6 |
| LY SC 150mg (Part A) Single dose of LY3113593 administered subcutaneously (SC) at 150 mg. | 6 |
| Placebo IV (Part B) Single dose of placebo matching LY3113593 administered IV. | 2 |
| LY IV 150mg (Part B) Single dose of LY3113593 administered IV at 150 mg. | 6 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | LY SC 150mg (Part A) | Total | LY IV 150mg (Part A) | Placebo (Part A) | LY IV 1.5mg (Part A) | LY IV 5mg (Part A) | LY IV 15mg (Part A) | LY IV 50mg (Part A) | LY IV 400mg (Part A) | Placebo IV (Part B) | LY IV 150mg (Part B) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Part A | 43.7 years STANDARD_DEVIATION 13.05 | 39.1 years STANDARD_DEVIATION 11.49 | 46.3 years STANDARD_DEVIATION 8.89 | 37.8 years STANDARD_DEVIATION 10.69 | 45.0 years STANDARD_DEVIATION 7.4 | 31.0 years STANDARD_DEVIATION 5.22 | 30.7 years STANDARD_DEVIATION 4.41 | 41.5 years STANDARD_DEVIATION 21 | 38.3 years STANDARD_DEVIATION 7.55 | — | — |
| Age, Continuous Part B | — | 48.4 years STANDARD_DEVIATION 9.35 | — | — | — | — | — | — | — | 38.5 years STANDARD_DEVIATION 13.44 | 51.7 years STANDARD_DEVIATION 5.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 13 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 51 Participants | 5 Participants | 12 Participants | 2 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 12 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 22 Participants | 1 Participants | 4 Participants | 1 Participants | 6 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 28 Participants | 1 Participants | 7 Participants | 4 Participants | 0 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 6 Participants | 64 Participants | 6 Participants | 14 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 9 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 55 Participants | 2 Participants | 13 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 2 Participants | 4 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 | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 14 | 3 / 6 | 2 / 6 | 2 / 6 | 5 / 6 | 3 / 6 | 2 / 6 | 2 / 6 | 0 / 2 | 3 / 6 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 1 / 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
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through end of study (Day 85)
Population: All enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (Part A) | 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 IV 1.5mg (Part A) | 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 IV 5mg (Part A) | 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 IV 15mg (Part A) | 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 IV 50mg (Part A) | 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 IV 150mg (Part A) | 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 IV 400mg (Part A) | 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 SC 150mg (Part A) | 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 |
| Placebo IV (Part B) | 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 IV 150mg (Part B) | 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
Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593
Time frame: Baseline, Day 85
Population: All enrolled participants who received at least one dose of study drug and had baseline and post baseline Tsat profile data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 11.00 percentage of change | Standard Deviation 22 |
| LY IV 1.5mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 6.80 percentage of change | Standard Deviation 10 |
| LY IV 5mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 14.80 percentage of change | Standard Deviation 18 |
| LY IV 15mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 15.70 percentage of change | Standard Deviation 11 |
| LY IV 50mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 12.80 percentage of change | Standard Deviation 23 |
| LY IV 150mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 21.00 percentage of change | Standard Deviation 8.6 |
| LY IV 400mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 07.80 percentage of change | Standard Deviation 6.65 |
| LY SC 150mg (Part A) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 17.00 percentage of change | Standard Deviation 16 |
| Placebo IV (Part B) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | -0.50 percentage of change | Standard Deviation 14.9 |
| LY IV 150mg (Part B) | Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593 | 18.30 percentage of change | Standard Deviation 18.1 |
Secondary
Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593
Time frame: Baseline, Day 85
Population: All enrolled participants who received at least one dose of study drug and had baseline and post baseline Hb profile data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.269 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.455 |
| LY IV 1.5mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.425 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.363 |
| LY IV 5mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.123 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.486 |
| LY IV 15mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.205 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.468 |
| LY IV 50mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.780 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.38 |
| LY IV 150mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.508 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.65 |
| LY IV 400mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.165 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.796 |
| LY SC 150mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.217 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.306 |
| Placebo IV (Part B) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.375 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.361 |
| LY IV 150mg (Part B) | Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593 | 0.568 millimoles per liter of iron (mml/L-Fe) | Standard Deviation 0.444 |
Secondary
Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593
Time frame: Baseline, Day 85
Population: All enrolled participants who received at least one dose of study drug and had baseline and post baseline iron profile data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 6.78 micromoles per liter (μmol/L) | Standard Deviation 12.5 |
| LY IV 1.5mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 4.12 micromoles per liter (μmol/L) | Standard Deviation 5.49 |
| LY IV 5mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 9.46 micromoles per liter (μmol/L) | Standard Deviation 11.6 |
| LY IV 15mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 8.38 micromoles per liter (μmol/L) | Standard Deviation 5.22 |
| LY IV 50mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 10.23 micromoles per liter (μmol/L) | Standard Deviation 10.8 |
| LY IV 150mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 13.5 micromoles per liter (μmol/L) | Standard Deviation 5.68 |
| LY IV 400mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 7.9 micromoles per liter (μmol/L) | Standard Deviation 9.67 |
| LY SC 150mg (Part A) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 6.97 micromoles per liter (μmol/L) | Standard Deviation 14.4 |
| Placebo IV (Part B) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 3.3 micromoles per liter (μmol/L) | Standard Deviation 1.98 |
| LY IV 150mg (Part B) | Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593 | 7.92 micromoles per liter (μmol/L) | Standard Deviation 6.68 |
Secondary
Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios
Time frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
Population: All enrolled participants who received at least one dose of 150mg LY3113593 study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios | 7640000 ng*h/mL | Geometric Coefficient of Variation 37 |
| LY IV 1.5mg (Part A) | Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios | 17000000 ng*h/mL | Geometric Coefficient of Variation 28 |
90% CI: [0.34, 0.6]
Secondary
Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593
Time frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
Population: All enrolled participants who received at least one dose of LY3113593 study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 55700 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 29 |
| LY IV 1.5mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 280000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 14 |
| LY IV 5mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 1100000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 9 |
| LY IV 15mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 5240000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 17 |
| LY IV 50mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 17000000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 28 |
| LY IV 150mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 38300000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 17 |
| LY IV 400mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 7640000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 37 |
| LY SC 150mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593 | 8270000 nanograms*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593
Time frame: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85
Population: All enrolled participants who received at least one dose of LY3113593 study drug.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 559 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 15 |
| LY IV 1.5mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 2070 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 14 |
| LY IV 5mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 6330 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 13 |
| LY IV 15mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 20000 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 19 |
| LY IV 50mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 60800 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 34 |
| LY IV 150mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 170000 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 13 |
| LY IV 400mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 11300 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| LY SC 150mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593 | 38000 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 31 |