Diabetes Mellitus, Type 2
Conditions
Brief summary
The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study consists of two parts. Part A will study healthy participants in up to 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 weeks.
Interventions
DRUGPlacebo
Administered orally as capsules
DRUGLY2922470
Administered orally as capsules
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
For all participants: * Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes * Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m\^2) * Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study For participants with Type 2 Diabetes Mellitus (T2DM): * Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening. * Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening
Exclusion criteria
For all participants: * Are currently participating in another clinical study or completed one in the last 30 days * Are allergic to LY2922470 or other related drugs * 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 * Are infected with human immunodeficiency virus (HIV) * Have donated more than 450 milliliter (mL) of blood in the last 3 months or if have donated any blood in the last month * Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits) * Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic. For participants with T2DM: * Have had heart disease or stroke within 6 months before entering the study * Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor * Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months * Have used insulin to control diabetes in the last 1 year * Show symptoms of high blood sugar, for example (e.g.), frequent urination, always feeling thirsty, or unexpected weight loss
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 33 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 | Description |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose | — |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose | — |
| Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose | Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error. |
| Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose | LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error. |
Countries
Singapore
Participant flow
Pre-assignment details
This is a 2-part dose escalation study: Part A in healthy participants and Part B in participants with type 2 diabetes mellitus (T2DM). Participants in Part A participated in up to 4 intervention periods and participants in Part B participated in up to 3 intervention periods. There was an at least 8 days washout interval between each dosing.
Participants by arm
| Arm | Count |
|---|---|
| Part A Cohort 1 Sequence 1 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470; | 2 |
| Part A Cohort 1 Sequence 2 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo; | 2 |
| Part A Cohort 1 Sequence 3 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470; | 2 |
| Part A Cohort 1 Sequence 4 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470; | 2 |
| Part A Cohort 2 Sequence 1 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470; | 2 |
| Part A Cohort 2 Sequence 2 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo; | 2 |
| Part A Cohort 2 Sequence 3 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470; | 3 |
| Part A Cohort 2 Sequence 4 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470; | 2 |
| Part B Sequence 1 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470; | 3 |
| Part B Sequence 2 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo; | 3 |
| Part B Sequence 3 Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470; | 3 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 3 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A Cohort 1 Sequence 2 | Part A Cohort 1 Sequence 3 | Part A Cohort 1 Sequence 4 | Part A Cohort 2 Sequence 1 | Part A Cohort 2 Sequence 2 | Part A Cohort 2 Sequence 3 | Part A Cohort 1 Sequence 1 | Part A Cohort 2 Sequence 4 | Part B Sequence 1 | Part B Sequence 2 | Part B Sequence 3 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 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 | 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 | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 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) More than one race | 0 Participants | 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) 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 | 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 | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Singapore | 26 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 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 | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 15 | 1 / 6 | 1 / 6 | 2 / 6 | 3 / 6 | 3 / 6 | 3 / 6 | 1 / 6 | 2 / 6 | 3 / 9 | 3 / 6 | 2 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 15 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 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
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 to study completion up to 33 days
Population: All enrolled participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
| 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 |
| 1 mg (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 |
| 3 mg (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 |
| 10 mg (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 |
| 30 mg (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 |
| 90 mg (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 |
| 270 mg (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 |
| 540 mg (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 |
| 1350 mg (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 (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 |
| 270 mg (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 |
| 540 mg (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 |
| 1080 mg (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
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Time frame: Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
Population: All participants who received at least 1 dose of study drug with both baseline and 24 hours postdose glucose AUEC(0-24) values. Participants were analyzed based on the treatment they received.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 6.88 millimoles*hour/Liter (mmol*h/L) | Standard Error 1.52 |
| 1 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 10.49 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.64 |
| 3 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 1.29 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.67 |
| 10 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 8.20 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.46 |
| 30 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 2.04 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.43 |
| 90 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 3.68 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.47 |
| 270 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 10.76 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.37 |
| 540 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | -0.34 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.46 |
| 1350 mg (Part A) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | 7.34 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.61 |
| Placebo (Part B) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | -11.47 millimoles*hour/Liter (mmol*h/L) | Standard Error 3.68 |
| 270 mg (Part B) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | -19.95 millimoles*hour/Liter (mmol*h/L) | Standard Error 9.08 |
| 540 mg (Part B) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | -21.01 millimoles*hour/Liter (mmol*h/L) | Standard Error 9.1 |
| 1080 mg (Part B) | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)] | -27.19 millimoles*hour/Liter (mmol*h/L) | Standard Error 9.07 |
Secondary
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Time frame: Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
Population: All participants who received at least 1 dose of study drug with both baseline and 6 hours postdose C-peptide AUEC(0-6) values. Participants were analyzed based on the treatment they received.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 7349.88 picomoles*hour/Liter (pmol*h/L) | Standard Error 871.01 |
| 1 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 6314.08 picomoles*hour/Liter (pmol*h/L) | Standard Error 1257.47 |
| 3 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 6270.86 picomoles*hour/Liter (pmol*h/L) | Standard Error 1262.57 |
| 10 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 5465.01 picomoles*hour/Liter (pmol*h/L) | Standard Error 1257.11 |
| 30 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 6351.84 picomoles*hour/Liter (pmol*h/L) | Standard Error 1242.12 |
| 90 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 6651.32 picomoles*hour/Liter (pmol*h/L) | Standard Error 1264.87 |
| 270 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 7472.28 picomoles*hour/Liter (pmol*h/L) | Standard Error 1259.71 |
| 540 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 6499.90 picomoles*hour/Liter (pmol*h/L) | Standard Error 1263.96 |
| 1350 mg (Part A) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 6442.33 picomoles*hour/Liter (pmol*h/L) | Standard Error 1307.48 |
| Placebo (Part B) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 1518.13 picomoles*hour/Liter (pmol*h/L) | Standard Error 560.25 |
| 270 mg (Part B) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 1657.94 picomoles*hour/Liter (pmol*h/L) | Standard Error 1428.92 |
| 540 mg (Part B) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 5496.32 picomoles*hour/Liter (pmol*h/L) | Standard Error 1430.24 |
| 1080 mg (Part B) | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)] | 1790.26 picomoles*hour/Liter (pmol*h/L) | Standard Error 1428.57 |
Secondary
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
Time frame: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 52.1 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 30 |
| 1 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 194 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 26 |
| 3 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 658 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 33 |
| 10 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 2340 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 24 |
| 30 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 6110 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 20 |
| 90 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 13300 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 31 |
| 270 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 23900 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 50 |
| 540 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 50200 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 46 |
| 1350 mg (Part A) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 15200 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 31 |
| Placebo (Part B) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 33700 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 30 |
| 270 mg (Part B) | Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)] | 78200 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 42 |
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Time frame: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Population: All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate Cmax. Participants were analyzed based on the treatment they received.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 11.1 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 15 |
| 1 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 30.5 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 33 |
| 3 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 111 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
| 10 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 457 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
| 30 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 1030 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 33 |
| 90 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 2320 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 21 |
| 270 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 4130 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
| 540 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 6050 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 50 |
| 1350 mg (Part A) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 2000 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
| Placebo (Part B) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 3780 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 56 |
| 270 mg (Part B) | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | 7950 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 30 |