Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.
Detailed description
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo. Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data. The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.
Interventions
DRUGLY3009385
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are a healthy male or a female who cannot become pregnant * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2) at screening * Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study * Have veins suitable for easy blood collection * Are reliable and willing to be available for the whole study and be willing to follow study procedures * Have given consent to participate in this study
Exclusion criteria
* Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days * Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study * Have received live vaccine(s) within 1 month of screening, or intend to during the study * Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing * Have a weakened immune system * Have previously completed or withdrawn from this study * Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study * Have electrocardiogram (ECG) readings that are not suitable for the study * Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study * Have a history of drug or alcohol abuse * Are infected with hepatitis B * Are infected with human immunodeficiency virus (HIV) * Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month * Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period * Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic * Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit * Are deemed unsuitable to participate by the study doctor for any other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Baseline through Day 28 | The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE 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 serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) | Predose through Day 28 | The maximum observed plasma concentration (Cmax) of LY3009385 is summarized. |
| Change in Level of Blood Glucose Before and After a Standard Meal | Baseline, Day 5, and Day 14 | The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm. |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | Predose through Day 28 | LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized. |
| Change in Level of Glucagon Before and After a Standard Meal | Baseline, Day 14 | The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm. |
| Number of Participants Forming Antibody to LY3009385 | Baseline through Day 28 | The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline. |
| Change in Level of C-peptide Before and After a Standard Meal | Baseline, Day 5, and Day 14 | The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm. |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.3 mg LY3009385 LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 5 |
| 1 mg LY3009385 LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 6 |
| 3 mg LY3009385 LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 6 |
| 9 mg LY3009385 LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 6 |
| 22 mg LY3009385 LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 6 |
| 54 mg LY3009385 LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 | 5 |
| Placebo Placebo: saline, subcutaneous (SC) injection, single dose on Day 1 | 6 |
| Total | 40 |
Baseline characteristics
| Characteristic | 0.3 mg LY3009385 | 1 mg LY3009385 | 3 mg LY3009385 | 9 mg LY3009385 | 22 mg LY3009385 | 54 mg LY3009385 | Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 13.5 | 36.7 years STANDARD_DEVIATION 12.5 | 33.3 years STANDARD_DEVIATION 14 | 31.7 years STANDARD_DEVIATION 8.4 | 34.7 years STANDARD_DEVIATION 10.4 | 34.6 years STANDARD_DEVIATION 9.9 | 27.5 years STANDARD_DEVIATION 4.3 | 33.8 years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting Blood Glucose | 82.84 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 4.99 | 92.40 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 4.86 | 84.45 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 10.6 | 96.02 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 8.35 | 89.40 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 6.29 | 92.46 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 11.12 | 89.08 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 5.17 | 89.62 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 8.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 40 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Singapore | 5 participants | 6 participants | 6 participants | 6 participants | 6 participants | 5 participants | 6 participants | 40 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants | 38 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 | 5 / 5 | 6 / 6 | 6 / 6 | 5 / 6 | 6 / 6 | 5 / 5 | 5 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE 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 serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline through Day 28
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.3 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
| 0.3 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 1 participants |
| 1 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 1 participants |
| 1 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
| 3 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
| 3 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 1 participants |
| 9 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 2 participants |
| 9 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
| 22 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
| 22 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 5 participants |
| 54 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 5 participants |
| 54 mg LY3009385 | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
| Placebo | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Study Drug-Related AEs | 2 participants |
| Placebo | Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs | Serious AEs | 0 participants |
Secondary
Change in Level of Blood Glucose Before and After a Standard Meal
The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Time frame: Baseline, Day 5, and Day 14
Population: Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.3 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | NA milligrams times hours per deciliter | — |
| 0.3 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 76.54 milligrams times hours per deciliter | Standard Deviation 56.51 |
| 1 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | -45.35 milligrams times hours per deciliter | Standard Deviation 18.27 |
| 1 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | NA milligrams times hours per deciliter | — |
| 3 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | 42.30 milligrams times hours per deciliter | Standard Deviation 33.69 |
| 3 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | -8.44 milligrams times hours per deciliter | Standard Deviation 45.83 |
| 9 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | -60.57 milligrams times hours per deciliter | Standard Deviation 52.29 |
| 9 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | -14.50 milligrams times hours per deciliter | Standard Deviation 36.92 |
| 22 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | -31.33 milligrams times hours per deciliter | Standard Deviation 38.43 |
| 22 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | 5.16 milligrams times hours per deciliter | Standard Deviation 38.48 |
| 54 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | -108.93 milligrams times hours per deciliter | Standard Deviation 25.67 |
| 54 mg LY3009385 | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | -129.75 milligrams times hours per deciliter | Standard Deviation 27.55 |
| Placebo | Change in Level of Blood Glucose Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | -3.54 milligrams times hours per deciliter | Standard Deviation 54.72 |
| Placebo | Change in Level of Blood Glucose Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 4.73 milligrams times hours per deciliter | Standard Deviation 30.43 |
Secondary
Change in Level of C-peptide Before and After a Standard Meal
The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.
Time frame: Baseline, Day 5, and Day 14
Population: Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.3 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 932.50 picomoles times hours per liter | Standard Deviation 2402.47 |
| 0.3 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | NA picomoles times hours per liter | — |
| 1 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 2235.08 picomoles times hours per liter | Standard Deviation 1204.19 |
| 1 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | NA picomoles times hours per liter | — |
| 3 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 982.50 picomoles times hours per liter | Standard Deviation 1104.62 |
| 3 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | -363.92 picomoles times hours per liter | Standard Deviation 1174.13 |
| 9 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 1510.58 picomoles times hours per liter | Standard Deviation 1289.05 |
| 9 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | 1324.75 picomoles times hours per liter | Standard Deviation 2627.97 |
| 22 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 640.25 picomoles times hours per liter | Standard Deviation 1572.44 |
| 22 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | 511.67 picomoles times hours per liter | Standard Deviation 786.06 |
| 54 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | -116.50 picomoles times hours per liter | Standard Deviation 1414.08 |
| 54 mg LY3009385 | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | 955.40 picomoles times hours per liter | Standard Deviation 1463.97 |
| Placebo | Change in Level of C-peptide Before and After a Standard Meal | Day 5 (n= 5, 6, 6, 6, 6, 5, 6) | 866.50 picomoles times hours per liter | Standard Deviation 1954.39 |
| Placebo | Change in Level of C-peptide Before and After a Standard Meal | Day 14 (n= 0, 0, 6, 6, 6, 5, 4) | -959.13 picomoles times hours per liter | Standard Deviation 2164.81 |
Secondary
Change in Level of Glucagon Before and After a Standard Meal
The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.
Time frame: Baseline, Day 14
Population: Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg LY3009385 | Change in Level of Glucagon Before and After a Standard Meal | 0.93 picomoles per liter | Standard Deviation 2.66 |
| 1 mg LY3009385 | Change in Level of Glucagon Before and After a Standard Meal | -1.05 picomoles per liter | Standard Deviation 2.59 |
| 3 mg LY3009385 | Change in Level of Glucagon Before and After a Standard Meal | 0.68 picomoles per liter | Standard Deviation 2.46 |
| 9 mg LY3009385 | Change in Level of Glucagon Before and After a Standard Meal | 0.68 picomoles per liter | Standard Deviation 2.52 |
| 22 mg LY3009385 | Change in Level of Glucagon Before and After a Standard Meal | 0.48 picomoles per liter | Standard Deviation 6.15 |
Secondary
Number of Participants Forming Antibody to LY3009385
The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.
Time frame: Baseline through Day 28
Population: Participants who received a dose of LY3009385 or Placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.3 mg LY3009385 | Number of Participants Forming Antibody to LY3009385 | 1 participants |
| 1 mg LY3009385 | Number of Participants Forming Antibody to LY3009385 | 2 participants |
| 3 mg LY3009385 | Number of Participants Forming Antibody to LY3009385 | 2 participants |
| 9 mg LY3009385 | Number of Participants Forming Antibody to LY3009385 | 2 participants |
| 22 mg LY3009385 | Number of Participants Forming Antibody to LY3009385 | 2 participants |
| 54 mg LY3009385 | Number of Participants Forming Antibody to LY3009385 | 0 participants |
| Placebo | Number of Participants Forming Antibody to LY3009385 | 0 participants |
Secondary
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385
LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC\[0-inf\]) is summarized.
Time frame: Predose through Day 28
Population: Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg LY3009385 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | 4.81 micrograms times hours per milliliter | Geometric Coefficient of Variation 76 |
| 1 mg LY3009385 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | 9.49 micrograms times hours per milliliter | Geometric Coefficient of Variation 213 |
| 3 mg LY3009385 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | 53.1 micrograms times hours per milliliter | Geometric Coefficient of Variation 54 |
| 9 mg LY3009385 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | 214 micrograms times hours per milliliter | Geometric Coefficient of Variation 42 |
| 22 mg LY3009385 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | 757 micrograms times hours per milliliter | Geometric Coefficient of Variation 59 |
| 54 mg LY3009385 | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385 | 1670 micrograms times hours per milliliter | Geometric Coefficient of Variation 27 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax)
The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.
Time frame: Predose through Day 28
Population: Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 0.3 mg LY3009385 | Pharmacokinetics: Maximum Concentration (Cmax) | 14.1 nanograms per milliliter | Geometric Coefficient of Variation 41 |
| 1 mg LY3009385 | Pharmacokinetics: Maximum Concentration (Cmax) | 51.9 nanograms per milliliter | Geometric Coefficient of Variation 118 |
| 3 mg LY3009385 | Pharmacokinetics: Maximum Concentration (Cmax) | 180 nanograms per milliliter | Geometric Coefficient of Variation 46 |
| 9 mg LY3009385 | Pharmacokinetics: Maximum Concentration (Cmax) | 847 nanograms per milliliter | Geometric Coefficient of Variation 36 |
| 22 mg LY3009385 | Pharmacokinetics: Maximum Concentration (Cmax) | 2030 nanograms per milliliter | Geometric Coefficient of Variation 14 |
| 54 mg LY3009385 | Pharmacokinetics: Maximum Concentration (Cmax) | 4810 nanograms per milliliter | Geometric Coefficient of Variation 19 |