| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | | Number | | participants | | Day 1 up to 10 days after last dose of study medication (up to 11 days) | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg | Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1. | | OG004 | PF-04937319 480 mg | Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1. | | OG005 | PF-04937319 640 mg | Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1. | | OG006 | Placebo | Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1. |
| | | Title | Denominators | Categories |
|---|
| AEs | | |
| |
| Secondary | Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1 | Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram*deciliter*hour [ng*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*milliliter*hour [mg*mL*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm group, respectively. | Posted | | Mean | Standard Deviation | (ng*dL*hour)/(mg*mL*hour) | | -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hours pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | |
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast). | Pharmacokinetic (PK) parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg | |
|
| Primary | Maximum Observed Plasma Concentration (Cmax) | | PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg | Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1. | |
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | | PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg | Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1. | | OG004 |
|
| Primary | Apparent Oral Clearance (CL/F) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute (mL/min) | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg | |
|
| Primary | Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg |
|
| Primary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Mean | Standard Deviation | hour | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg | Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1. |
|
| Secondary | Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1 | Percent change from baseline in post-prandial area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. |
|
| Secondary | Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1 | Percent change from baseline in post-prandial area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. |
|
| Secondary | Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1 | Percent change from baseline in post-prandial area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Mean | Standard Deviation | percent change | | -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. |
|
| Secondary | Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1 | Ratio of insulin delta C30 (in terms of milliunits*deciliter [mU*dL]) to glucose delta C30 (in terms of milligram*liter [mg*liter]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Mean | Standard Deviation | (mU*dL)/(mg*Liter) | | -46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | |
|
| Secondary | Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) | Ratio of C-peptide Delta C30 (in terms of nanogram*deciliter [ng*dL]) to glucose delta C30 (in terms of milligram*milliliter [mg*mL]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Mean | Standard Deviation | (ng*dL)/(mg*mL) | | -46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | |
|
| Secondary | Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1 | Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit*deciliter*hour [mU*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*liter*hour [mg*liter*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1. | PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. 'N' (number of participants analyzed) signifies participants evaluable for this measure and 'n' signifies participants evaluable at specified time point for each arm group, respectively. | Posted | | Mean | Standard Deviation | (mU*dL*hour)/(mg*liter*hour) | | -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | |
|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time. | PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter | | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 10 mg | Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1. | | OG001 | PF-04937319 30 mg | Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1. | | OG002 | PF-04937319 100 mg | Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1. | | OG003 | PF-04937319 300 mg |
|