Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.
Interventions
DRUGPlacebo
Administered orally as capsules
DRUGLY2922470
Administered orally as capsules
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
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes * Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening * Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening * Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m\^2) * Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Exclusion criteria
* Are currently participating in another clinical study or completed one in the last 30 days * Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study * Have electrocardiogram (ECG) readings that are not suitable for the study * Are infected with hepatitis B or hepatitis C * Are infected with human immunodeficiency virus (HIV) * Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
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 Study Completion (up to 56 days) | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose |
| Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose |
| Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose |
| Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | Baseline, Day 28 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo QD or BID Placebo administered orally QD or BID for up to 28 days. | 14 |
| 60 mg LY2922470 QD 60 mg LY2922470 administered orally QD for up to 28 days. | 8 |
| 200 mg LY2922470 QD 200 mg LY2922470 administered orally QD for up to 28 days. | 8 |
| 500 mg LY2922470 QD 500 mg LY2922470 administered orally QD for up to 28 days. | 8 |
| 1200 mg LY2922470 QD 1200 mg LY2922470 administered orally QD for up to 28 days. | 9 |
| 150 mg LY2922470 BID 150 mg LY2922470 administered orally BID for up to 28 days. | 8 |
| 400 mg LY2922470 BID 400 mg LY2922470 administered orally BID for up to 28 days. | 9 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Unable to Place Catheter for Blood Draws | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo QD or BID | Total | 400 mg LY2922470 BID | 150 mg LY2922470 BID | 1200 mg LY2922470 QD | 500 mg LY2922470 QD | 200 mg LY2922470 QD | 60 mg LY2922470 QD |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 9.9 | 54.9 years STANDARD_DEVIATION 8.7 | 50.2 years STANDARD_DEVIATION 9.3 | 54.0 years STANDARD_DEVIATION 6.4 | 59.8 years STANDARD_DEVIATION 7.6 | 58.6 years STANDARD_DEVIATION 7.8 | 52.8 years STANDARD_DEVIATION 8 | 59.9 years STANDARD_DEVIATION 6.6 |
| Body Mass Index (BMI) | 31.00 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.86 | 31.19 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.89 | 32.90 kilograms per square meter (kg/m²) STANDARD_DEVIATION 6.08 | 34.36 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.04 | 30.20 kilograms per square meter (kg/m²) STANDARD_DEVIATION 6.56 | 31.08 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.4 | 30.76 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.74 | 28.10 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 27 Participants | 6 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 37 Participants | 3 Participants | 3 Participants | 5 Participants | 6 Participants | 7 Participants | 7 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 | 145.92 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 50.5 | 141.05 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 40.99 | 149.56 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 44.21 | 149.50 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 38.4 | 137.11 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 26.19 | 140.19 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 49.53 | 132.39 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 37.09 | 128.45 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 39.38 |
| Hemoglobin A1c (HbA1c) | 8.29 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.08 | 7.99 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.24 | 7.96 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.21 | 8.09 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.25 | 7.24 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.49 | 7.91 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.69 | 7.74 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.29 | 8.58 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.48 |
| 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 25 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 5 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 | 1 Participants | 1 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 | 11 Participants | 38 Participants | 7 Participants | 5 Participants | 6 Participants | 3 Participants | 3 Participants | 3 Participants |
| Region of Enrollment United States | 14 Participants | 64 Participants | 9 Participants | 8 Participants | 9 Participants | 8 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Female | 4 Participants | 22 Participants | 4 Participants | 4 Participants | 4 Participants | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 10 Participants | 42 Participants | 5 Participants | 4 Participants | 5 Participants | 7 Participants | 5 Participants | 6 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 / 14 | 3 / 8 | 4 / 8 | 4 / 8 | 5 / 9 | 1 / 8 | 6 / 9 |
| serious Total, serious adverse events | 0 / 14 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 9 |
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline through Study Completion (up to 56 days)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo QD or BID | 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 |
| 60 mg LY2922470 QD | 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 |
| 200 mg LY2922470 QD | 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 |
| 500 mg LY2922470 QD | 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 |
| 1200 mg LY2922470 QD | 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 |
| 150 mg LY2922470 BID | 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 |
| 400 mg LY2922470 BID | 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
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28
Time frame: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose
Population: All participants who received study drug and had sufficient evaluable blood glucose values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD or BID | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | 21.7 mg*h/dL | Standard Deviation 724 |
| 60 mg LY2922470 QD | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | -93 mg*h/dL | Standard Deviation 165 |
| 200 mg LY2922470 QD | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | 70.4 mg*h/dL | Standard Deviation 1160 |
| 500 mg LY2922470 QD | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | -499 mg*h/dL | Standard Deviation 493 |
| 1200 mg LY2922470 QD | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | -205 mg*h/dL | Standard Deviation 583 |
| 150 mg LY2922470 BID | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | -531 mg*h/dL | Standard Deviation 549 |
| 400 mg LY2922470 BID | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | -621 mg*h/dL | Standard Deviation 943 |
Secondary
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28
Time frame: Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose
Population: All participants who received study drug and had sufficient evaluable c-peptide values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD or BID | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | 665 picomoles*h per liter (pmol*h/L) | Standard Deviation 4970 |
| 60 mg LY2922470 QD | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | 147 picomoles*h per liter (pmol*h/L) | Standard Deviation 3560 |
| 200 mg LY2922470 QD | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | 793 picomoles*h per liter (pmol*h/L) | Standard Deviation 4220 |
| 500 mg LY2922470 QD | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | -159 picomoles*h per liter (pmol*h/L) | Standard Deviation 3780 |
| 1200 mg LY2922470 QD | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | -740 picomoles*h per liter (pmol*h/L) | Standard Deviation 2890 |
| 150 mg LY2922470 BID | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | 1230 picomoles*h per liter (pmol*h/L) | Standard Deviation 1660 |
| 400 mg LY2922470 BID | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | -2230 picomoles*h per liter (pmol*h/L) | Standard Deviation 2810 |
Secondary
Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28
Time frame: Baseline, Day 28
Population: All participants who received study drug and had sufficient evaluable HbA1c values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo QD or BID | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | -0.38 percentage of glycosylated hemoglobin | Standard Deviation 0.45 |
| 60 mg LY2922470 QD | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | -0.54 percentage of glycosylated hemoglobin | Standard Deviation 0.32 |
| 200 mg LY2922470 QD | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | -0.43 percentage of glycosylated hemoglobin | Standard Deviation 0.58 |
| 500 mg LY2922470 QD | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | -0.24 percentage of glycosylated hemoglobin | Standard Deviation 0.52 |
| 1200 mg LY2922470 QD | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | -0.16 percentage of glycosylated hemoglobin | Standard Deviation 0.67 |
| 150 mg LY2922470 BID | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | -0.34 percentage of glycosylated hemoglobin | Standard Deviation 0.38 |
| 400 mg LY2922470 BID | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | 0.01 percentage of glycosylated hemoglobin | Standard Deviation 0.44 |
Secondary
Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470
Time frame: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose
Population: All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD or BID | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1 | 4220 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 52 |
| Placebo QD or BID | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 28 | 5660 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 31 |
| 60 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1 | 11,600 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 27 |
| 60 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 28 | 15,300 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 43 |
| 200 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1 | 25,100 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 30 |
| 200 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 28 | 25,000 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 47 |
| 500 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1 | 81,400 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 34 |
| 500 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 28 | 65,300 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 49 |
| 1200 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1 | 21,000 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 47 |
| 1200 mg LY2922470 QD | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 28 | 21,300 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 51 |
| 150 mg LY2922470 BID | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1 | 50,700 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 45 |
| 150 mg LY2922470 BID | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 28 | 44,800 nanograms*hour/milliliter (ng*h/mL) | Geometric Coefficient of Variation 38 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Time frame: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose
Population: All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD or BID | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1 | 723 ng/mL | Geometric Coefficient of Variation 39 |
| Placebo QD or BID | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 28 | 1070 ng/mL | Geometric Coefficient of Variation 32 |
| 60 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1 | 1540 ng/mL | Geometric Coefficient of Variation 23 |
| 60 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 28 | 1630 ng/mL | Geometric Coefficient of Variation 70 |
| 200 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1 | 2750 ng/mL | Geometric Coefficient of Variation 42 |
| 200 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 28 | 3410 ng/mL | Geometric Coefficient of Variation 33 |
| 500 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1 | 8200 ng/mL | Geometric Coefficient of Variation 38 |
| 500 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 28 | 7900 ng/mL | Geometric Coefficient of Variation 49 |
| 1200 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1 | 1510 ng/mL | Geometric Coefficient of Variation 54 |
| 1200 mg LY2922470 QD | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 28 | 1540 ng/mL | Geometric Coefficient of Variation 42 |
| 150 mg LY2922470 BID | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 1 | 3150 ng/mL | Geometric Coefficient of Variation 58 |
| 150 mg LY2922470 BID | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Day 28 | 2980 ng/mL | Geometric Coefficient of Variation 37 |
Secondary
Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470
Time frame: Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose
Population: All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo QD or BID | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1 | 1.50 hours |
| Placebo QD or BID | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 28 | 1.50 hours |
| 60 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1 | 2.50 hours |
| 60 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 28 | 3.92 hours |
| 200 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1 | 2.75 hours |
| 200 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 28 | 1.50 hours |
| 500 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1 | 4.00 hours |
| 500 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 28 | 2.50 hours |
| 1200 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1 | 2.00 hours |
| 1200 mg LY2922470 QD | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 28 | 1.51 hours |
| 150 mg LY2922470 BID | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1 | 2.50 hours |
| 150 mg LY2922470 BID | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 28 | 1.50 hours |