Diabetes Mellitus, Type 2, NIDDM
Conditions
Keywords
Pharmacokinetics PK Pharmacodynamics PD T2DM Phase 1 Type 2 diabetes mellitus safety and tolerability
Brief summary
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.
Interventions
Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.
Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with type 2 diabetes mellitus who are taking metformin only. * Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only. * Male and/or female patients (females will be women of non childbearing potential) * Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \>50 kg (110 lbs). * HbA1c between 7.0% and 10.0%.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible). * Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min * Any condition possibly affecting drug absorption (eg, gastrectomy) * History of stroke or transient ischemic attack or myocardial infarction within the past 6 months * History of coronary artery bypass graft or stent implantation. * Clinically significant peripheral vascular disease (eg, manifested by claudication). * Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV. * One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months. * Current history of angina/unstable angina. * Milk or soy allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -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 14 (fasted condition) | Percent change from baseline in 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. |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition) | AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours. |
| Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) | — |
| Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) | — |
| Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14 | 0 hour (pre-dose) through 24 hours post-dose on Day 14 | Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100. |
| Apparent Oral Clearance (CL/F) on Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Apparent Volume of Distribution (Vz/F) on Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) | 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. |
| Observed Accumulation Ratio for AUCtau (Rac) | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition) | Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours. |
| Observed Accumulation Ratio for Cmax (Rac, Cmax) | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition) | Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1. |
| Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | -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 (fasted condition) | Percent change from baseline in 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. |
| Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition) | — |
| Plasma Decay Half-Life (t1/2) on Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) | AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days) | An AE was any untoward medical occurrence in a participant who received study drug 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 drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. |
| Maximum Observed Plasma Concentration (Cmax) On Day 1 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition) | — |
| Maximum Observed Plasma Concentration (Cmax) On Day 6 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition) | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition) | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6 | 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | -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 and 14 (fasted condition) | Percent change from baseline in 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. |
| Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | -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 and 14 (fasted condition) | Percent change from baseline in 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. |
| Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | -46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14 | Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC \[0-24\]) divided by 24. |
| Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | — |
| Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) | Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids. |
| Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) | Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids. |
| Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) | Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids. |
| Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (Day 1), Day 6 and 14 | Baseline value was collected at 0 hour on Day 1 for lactate. |
| Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) | Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-04937319 10 mg Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days. | 9 |
| PF-04937319 30 mg Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days. | 9 |
| PF-04937319 50 mg Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days. | 9 |
| PF-04937319 100 mg Participants received PF-04937319 100 mg tablet orally once daily for 14 days. | 9 |
| PF-04937319 300 mg Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days. | 9 |
| Placebo Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days. | 16 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | PF-04937319 50 mg | PF-04937319 100 mg | PF-04937319 300 mg | Placebo | Total | PF-04937319 10 mg | PF-04937319 30 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 5.4 | 51.4 years STANDARD_DEVIATION 10.6 | 56.4 years STANDARD_DEVIATION 5.8 | 57.3 years STANDARD_DEVIATION 5.8 | 54.4 years STANDARD_DEVIATION 7.7 | 55.6 years STANDARD_DEVIATION 9.2 | 49.4 years STANDARD_DEVIATION 7.8 |
| Gender Female | 2 Participants | 3 Participants | 3 Participants | 6 Participants | 18 Participants | 4 Participants | 0 Participants |
| Gender Male | 7 Participants | 6 Participants | 6 Participants | 10 Participants | 43 Participants | 5 Participants | 9 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 9 | 5 / 9 | 0 / 9 | 3 / 9 | 8 / 9 | 5 / 16 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 16 |
Outcome results
Apparent Oral Clearance (CL/F) on Day 14
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Apparent Oral Clearance (CL/F) on Day 14 | 21.86 liter per hour | Geometric Coefficient of Variation 25 |
| PF-04937319 30 mg | Apparent Oral Clearance (CL/F) on Day 14 | 32.32 liter per hour | Geometric Coefficient of Variation 23 |
| PF-04937319 50 mg | Apparent Oral Clearance (CL/F) on Day 14 | 26.48 liter per hour | Geometric Coefficient of Variation 34 |
| PF-04937319 100 mg | Apparent Oral Clearance (CL/F) on Day 14 | 31.56 liter per hour | Geometric Coefficient of Variation 37 |
| PF-04937319 300 mg | Apparent Oral Clearance (CL/F) on Day 14 | 40.29 liter per hour | Geometric Coefficient of Variation 43 |
Apparent Volume of Distribution (Vz/F) on Day 14
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.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Apparent Volume of Distribution (Vz/F) on Day 14 | 205.3 liter | Geometric Coefficient of Variation 20 |
| PF-04937319 30 mg | Apparent Volume of Distribution (Vz/F) on Day 14 | 311.6 liter | Geometric Coefficient of Variation 32 |
| PF-04937319 50 mg | Apparent Volume of Distribution (Vz/F) on Day 14 | 236.7 liter | Geometric Coefficient of Variation 27 |
| PF-04937319 100 mg | Apparent Volume of Distribution (Vz/F) on Day 14 | 314.0 liter | Geometric Coefficient of Variation 28 |
| PF-04937319 300 mg | Apparent Volume of Distribution (Vz/F) on Day 14 | 475.2 liter | Geometric Coefficient of Variation 48 |
Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14
AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14 | 458.0 nanogram*hour per milliliter | Geometric Coefficient of Variation 35 |
| PF-04937319 30 mg | Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14 | 928.7 nanogram*hour per milliliter | Geometric Coefficient of Variation 23 |
| PF-04937319 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14 | 1889 nanogram*hour per milliliter | Geometric Coefficient of Variation 52 |
| PF-04937319 100 mg | Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14 | 3167 nanogram*hour per milliliter | Geometric Coefficient of Variation 40 |
| PF-04937319 300 mg | Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14 | 7446 nanogram*hour per milliliter | Geometric Coefficient of Variation 42 |
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1
AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1 | 407.0 nanogram*hour per milliliter | Geometric Coefficient of Variation 29 |
| PF-04937319 30 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1 | 867.7 nanogram*hour per milliliter | Geometric Coefficient of Variation 21 |
| PF-04937319 50 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1 | 1456 nanogram*hour per milliliter | Geometric Coefficient of Variation 48 |
| PF-04937319 100 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1 | 2749 nanogram*hour per milliliter | Geometric Coefficient of Variation 38 |
| PF-04937319 300 mg | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1 | 6034 nanogram*hour per milliliter | Geometric Coefficient of Variation 40 |
Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14 | 51.09 ng/mL | Geometric Coefficient of Variation 27 |
| PF-04937319 30 mg | Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14 | 79.30 ng/mL | Geometric Coefficient of Variation 31 |
| PF-04937319 50 mg | Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14 | 171.3 ng/mL | Geometric Coefficient of Variation 36 |
| PF-04937319 100 mg | Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14 | 251.5 ng/mL | Geometric Coefficient of Variation 44 |
| PF-04937319 300 mg | Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14 | 555.9 ng/mL | Geometric Coefficient of Variation 44 |
Maximum Observed Plasma Concentration (Cmax) On Day 1
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)
Population: Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Maximum Observed Plasma Concentration (Cmax) On Day 1 | 38.22 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 25 |
| PF-04937319 30 mg | Maximum Observed Plasma Concentration (Cmax) On Day 1 | 69.49 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| PF-04937319 50 mg | Maximum Observed Plasma Concentration (Cmax) On Day 1 | 119.4 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
| PF-04937319 100 mg | Maximum Observed Plasma Concentration (Cmax) On Day 1 | 245.4 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
| PF-04937319 300 mg | Maximum Observed Plasma Concentration (Cmax) On Day 1 | 449.3 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
Maximum Observed Plasma Concentration (Cmax) On Day 6
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Maximum Observed Plasma Concentration (Cmax) On Day 6 | 57.73 ng/mL | Geometric Coefficient of Variation 17 |
| PF-04937319 30 mg | Maximum Observed Plasma Concentration (Cmax) On Day 6 | 122.3 ng/mL | Geometric Coefficient of Variation 17 |
| PF-04937319 50 mg | Maximum Observed Plasma Concentration (Cmax) On Day 6 | 234.1 ng/mL | Geometric Coefficient of Variation 24 |
| PF-04937319 100 mg | Maximum Observed Plasma Concentration (Cmax) On Day 6 | 421.5 ng/mL | Geometric Coefficient of Variation 31 |
| PF-04937319 300 mg | Maximum Observed Plasma Concentration (Cmax) On Day 6 | 970.6 ng/mL | Geometric Coefficient of Variation 35 |
Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14 | 1.380 ng/mL | Geometric Coefficient of Variation 83 |
| PF-04937319 30 mg | Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14 | 10.56 ng/mL | Geometric Coefficient of Variation 43 |
| PF-04937319 50 mg | Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14 | 22.73 ng/mL | Geometric Coefficient of Variation 103 |
| PF-04937319 100 mg | Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14 | 41.68 ng/mL | Geometric Coefficient of Variation 64 |
| PF-04937319 300 mg | Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14 | 129.8 ng/mL | Geometric Coefficient of Variation 62 |
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug 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 drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04937319 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 participants |
| PF-04937319 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 participants |
| PF-04937319 50 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 participants |
| PF-04937319 50 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| PF-04937319 300 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 participants |
| PF-04937319 300 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 participants |
Observed Accumulation Ratio for AUCtau (Rac)
Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Observed Accumulation Ratio for AUCtau (Rac) | 1.204 ratio | Geometric Coefficient of Variation 22 |
| PF-04937319 30 mg | Observed Accumulation Ratio for AUCtau (Rac) | 1.069 ratio | Geometric Coefficient of Variation 15 |
| PF-04937319 50 mg | Observed Accumulation Ratio for AUCtau (Rac) | 1.296 ratio | Geometric Coefficient of Variation 24 |
| PF-04937319 100 mg | Observed Accumulation Ratio for AUCtau (Rac) | 1.152 ratio | Geometric Coefficient of Variation 22 |
| PF-04937319 300 mg | Observed Accumulation Ratio for AUCtau (Rac) | 1.118 ratio | Geometric Coefficient of Variation 40 |
Observed Accumulation Ratio for Cmax (Rac, Cmax)
Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Observed Accumulation Ratio for Cmax (Rac, Cmax) | 1.414 ratio | Geometric Coefficient of Variation 41 |
| PF-04937319 30 mg | Observed Accumulation Ratio for Cmax (Rac, Cmax) | 1.141 ratio | Geometric Coefficient of Variation 28 |
| PF-04937319 50 mg | Observed Accumulation Ratio for Cmax (Rac, Cmax) | 1.437 ratio | Geometric Coefficient of Variation 17 |
| PF-04937319 100 mg | Observed Accumulation Ratio for Cmax (Rac, Cmax) | 1.026 ratio | Geometric Coefficient of Variation 25 |
| PF-04937319 300 mg | Observed Accumulation Ratio for Cmax (Rac, Cmax) | 1.080 ratio | Geometric Coefficient of Variation 40 |
Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14
Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.
Time frame: 0 hour (pre-dose) through 24 hours post-dose on Day 14
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14 | 0.3904 percentage of dose | Standard Deviation 0.11901 |
| PF-04937319 30 mg | Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14 | 0.3533 percentage of dose | Standard Deviation 0.20183 |
| PF-04937319 50 mg | Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14 | 0.6463 percentage of dose | Standard Deviation 0.56717 |
| PF-04937319 100 mg | Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14 | 0.5380 percentage of dose | Standard Deviation 0.34593 |
| PF-04937319 300 mg | Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14 | 0.4294 percentage of dose | Standard Deviation 0.44676 |
Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1
Percent change from baseline in 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.
Time frame: -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 (fasted condition)
Population: Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | -0.46 percent change | Standard Deviation 8.881 |
| PF-04937319 30 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | -2.67 percent change | Standard Deviation 6.67 |
| PF-04937319 50 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | 6.41 percent change | Standard Deviation 14.532 |
| PF-04937319 100 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | -12.11 percent change | Standard Deviation 14.225 |
| PF-04937319 300 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | -12.29 percent change | Standard Deviation 13.711 |
| Placebo | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 | -3.71 percent change | Standard Deviation 10.848 |
Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14
Percent change from baseline in 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.
Time frame: -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 14 (fasted condition)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -11.94 percent change | Standard Deviation 15.477 |
| PF-04937319 30 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -4.91 percent change | Standard Deviation 16.601 |
| PF-04937319 50 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -4.11 percent change | Standard Deviation 17.321 |
| PF-04937319 100 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -26.83 percent change | Standard Deviation 21.054 |
| PF-04937319 300 mg | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -11.37 percent change | Standard Deviation 15.205 |
| Placebo | Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14 | -2.86 percent change | Standard Deviation 12.103 |
Plasma Decay Half-Life (t1/2) on Day 14
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 10 mg | Plasma Decay Half-Life (t1/2) on Day 14 | 6.563 hour | Standard Deviation 0.77897 |
| PF-04937319 30 mg | Plasma Decay Half-Life (t1/2) on Day 14 | 6.884 hour | Standard Deviation 1.9264 |
| PF-04937319 50 mg | Plasma Decay Half-Life (t1/2) on Day 14 | 6.348 hour | Standard Deviation 1.4271 |
| PF-04937319 100 mg | Plasma Decay Half-Life (t1/2) on Day 14 | 6.960 hour | Standard Deviation 1.0358 |
| PF-04937319 300 mg | Plasma Decay Half-Life (t1/2) on Day 14 | 8.479 hour | Standard Deviation 2.4173 |
Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04937319 10 mg | Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14 | 3.00 hour |
| PF-04937319 30 mg | Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14 | 3.00 hour |
| PF-04937319 50 mg | Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14 | 3.00 hour |
| PF-04937319 100 mg | Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14 | 3.00 hour |
| PF-04937319 300 mg | Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14 | 3.00 hour |
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04937319 10 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 | 3.00 hour |
| PF-04937319 30 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 | 3.00 hour |
| PF-04937319 50 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 | 3.00 hour |
| PF-04937319 100 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 | 3.00 hour |
| PF-04937319 300 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 | 3.00 hour |
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6
Time frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)
Population: PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04937319 10 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6 | 1.50 hour |
| PF-04937319 30 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6 | 1.50 hour |
| PF-04937319 50 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6 | 1.50 hour |
| PF-04937319 100 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6 | 1.50 hour |
| PF-04937319 300 mg | Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6 | 1.50 hour |
Change From Baseline in Average Plasma Glucose at Day 1, 6, 14
Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC \[0-24\]) divided by 24.
Time frame: -46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 6 (n=8,9,9,9,7,15) | -19.62 mg/dL | Standard Deviation 16.247 |
| PF-04937319 10 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 1 (n=9,9,9,9,9,16) | -7.18 mg/dL | Standard Deviation 9.851 |
| PF-04937319 10 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Baseline (n=9,9,9,9,9,16) | 192.10 mg/dL | Standard Deviation 22.913 |
| PF-04937319 10 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 14 (n=8,9,9,9,7,15) | -12.65 mg/dL | Standard Deviation 25.918 |
| PF-04937319 30 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 1 (n=9,9,9,9,9,16) | -5.24 mg/dL | Standard Deviation 6.421 |
| PF-04937319 30 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Baseline (n=9,9,9,9,9,16) | 188.83 mg/dL | Standard Deviation 48.992 |
| PF-04937319 30 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 6 (n=8,9,9,9,7,15) | -6.35 mg/dL | Standard Deviation 22.496 |
| PF-04937319 30 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 14 (n=8,9,9,9,7,15) | -16.45 mg/dL | Standard Deviation 27.709 |
| PF-04937319 50 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Baseline (n=9,9,9,9,9,16) | 195.78 mg/dL | Standard Deviation 37.871 |
| PF-04937319 50 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 14 (n=8,9,9,9,7,15) | -14.79 mg/dL | Standard Deviation 33.687 |
| PF-04937319 50 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 6 (n=8,9,9,9,7,15) | 9.80 mg/dL | Standard Deviation 30.359 |
| PF-04937319 50 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 1 (n=9,9,9,9,9,16) | 8.72 mg/dL | Standard Deviation 15.071 |
| PF-04937319 100 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 14 (n=8,9,9,9,7,15) | -48.87 mg/dL | Standard Deviation 27.216 |
| PF-04937319 100 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 6 (n=8,9,9,9,7,15) | -32.36 mg/dL | Standard Deviation 24.121 |
| PF-04937319 100 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Baseline (n=9,9,9,9,9,16) | 205.38 mg/dL | Standard Deviation 44.632 |
| PF-04937319 100 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 1 (n=9,9,9,9,9,16) | -1.90 mg/dL | Standard Deviation 21.784 |
| PF-04937319 300 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Baseline (n=9,9,9,9,9,16) | 170.95 mg/dL | Standard Deviation 51.465 |
| PF-04937319 300 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 6 (n=8,9,9,9,7,15) | -47.19 mg/dL | Standard Deviation 25.752 |
| PF-04937319 300 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 14 (n=8,9,9,9,7,15) | -34.15 mg/dL | Standard Deviation 24.596 |
| PF-04937319 300 mg | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 1 (n=9,9,9,9,9,16) | -23.26 mg/dL | Standard Deviation 19.189 |
| Placebo | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 14 (n=8,9,9,9,7,15) | -7.48 mg/dL | Standard Deviation 21.703 |
| Placebo | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 1 (n=9,9,9,9,9,16) | 3.04 mg/dL | Standard Deviation 17.611 |
| Placebo | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Change at Day 6 (n=8,9,9,9,7,15) | 3.92 mg/dL | Standard Deviation 17.068 |
| Placebo | Change From Baseline in Average Plasma Glucose at Day 1, 6, 14 | Baseline (n=9,9,9,9,9,16) | 189.07 mg/dL | Standard Deviation 39.131 |
Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Time frame: Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 14 (n=8,9,9,9,7,15) | -33.63 mg/dL | Standard Deviation 26.175 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 15 (n=8,9,9,9,7,15) | -13.38 mg/dL | Standard Deviation 22.595 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 4 (n=9,9,9,9,8,16) | -13.44 mg/dL | Standard Deviation 19.603 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 8 (n=8,9,9,9,7,15) | -23.25 mg/dL | Standard Deviation 21.212 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 7 (n=8,9,9,9,7,15) | -13.50 mg/dL | Standard Deviation 21.314 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 12 (n=8,9,9,9,7,15) | -27.13 mg/dL | Standard Deviation 28.423 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 3 (n=9,9,9,9,9,16) | -19.11 mg/dL | Standard Deviation 10.216 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 11 (n=8,9,9,9,7,15) | -17.38 mg/dL | Standard Deviation 28.54 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 5 (n=9,9,9,9,9,16) | -19.67 mg/dL | Standard Deviation 16.256 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 9 (n=8,9,9,9,7,15) | -19.63 mg/dL | Standard Deviation 20.784 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 2 (n=9,9,9,9,9,16) | -5.00 mg/dL | Standard Deviation 10.84 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (n=9,9,9,9,9,16) | 173.78 mg/dL | Standard Deviation 31.952 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 10 (n=8,9,9,9,7,15) | -23.88 mg/dL | Standard Deviation 23.503 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 13 (n=8,9,9,9,7,15) | -18.13 mg/dL | Standard Deviation 30.258 |
| PF-04937319 10 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 6 (n=9,9,9,9,7,15) | -10.89 mg/dL | Standard Deviation 18.21 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (n=9,9,9,9,9,16) | 181.33 mg/dL | Standard Deviation 50.621 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 2 (n=9,9,9,9,9,16) | -4.67 mg/dL | Standard Deviation 12.845 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 8 (n=8,9,9,9,7,15) | -8.56 mg/dL | Standard Deviation 20.415 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 7 (n=8,9,9,9,7,15) | -12.78 mg/dL | Standard Deviation 13.664 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 14 (n=8,9,9,9,7,15) | -23.67 mg/dL | Standard Deviation 25.441 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 13 (n=8,9,9,9,7,15) | -23.44 mg/dL | Standard Deviation 23.807 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 3 (n=9,9,9,9,9,16) | -5.78 mg/dL | Standard Deviation 10.171 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 6 (n=9,9,9,9,7,15) | -16.33 mg/dL | Standard Deviation 17.804 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 12 (n=8,9,9,9,7,15) | -18.56 mg/dL | Standard Deviation 28.183 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 4 (n=9,9,9,9,8,16) | -9.44 mg/dL | Standard Deviation 16.001 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 15 (n=8,9,9,9,7,15) | -21.44 mg/dL | Standard Deviation 26.034 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 11 (n=8,9,9,9,7,15) | -22.56 mg/dL | Standard Deviation 22.49 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 5 (n=9,9,9,9,9,16) | -9.89 mg/dL | Standard Deviation 15.358 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 10 (n=8,9,9,9,7,15) | -16.89 mg/dL | Standard Deviation 20.847 |
| PF-04937319 30 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 9 (n=8,9,9,9,7,15) | -22.11 mg/dL | Standard Deviation 20.709 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 12 (n=8,9,9,9,7,15) | -16.89 mg/dL | Standard Deviation 41.87 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (n=9,9,9,9,9,16) | 190.11 mg/dL | Standard Deviation 34.505 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 2 (n=9,9,9,9,9,16) | -6.78 mg/dL | Standard Deviation 25.43 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 3 (n=9,9,9,9,9,16) | -18.78 mg/dL | Standard Deviation 27.124 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 4 (n=9,9,9,9,8,16) | -13.78 mg/dL | Standard Deviation 28.9 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 5 (n=9,9,9,9,9,16) | -22.56 mg/dL | Standard Deviation 29.56 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 6 (n=9,9,9,9,7,15) | -18.00 mg/dL | Standard Deviation 34.38 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 7 (n=8,9,9,9,7,15) | -14.44 mg/dL | Standard Deviation 37.27 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 8 (n=8,9,9,9,7,15) | -5.56 mg/dL | Standard Deviation 37.964 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 9 (n=8,9,9,9,7,15) | -9.78 mg/dL | Standard Deviation 42.825 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 10 (n=8,9,9,9,7,15) | -16.33 mg/dL | Standard Deviation 32.427 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 11 (n=8,9,9,9,7,15) | -18.11 mg/dL | Standard Deviation 39.81 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 13 (n=8,9,9,9,7,15) | -24.78 mg/dL | Standard Deviation 40.822 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 14 (n=8,9,9,9,7,15) | -26.56 mg/dL | Standard Deviation 39.768 |
| PF-04937319 50 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 15 (n=8,9,9,9,7,15) | -23.89 mg/dL | Standard Deviation 38.238 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 9 (n=8,9,9,9,7,15) | -24.78 mg/dL | Standard Deviation 17.817 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 6 (n=9,9,9,9,7,15) | -29.11 mg/dL | Standard Deviation 16.027 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 11 (n=8,9,9,9,7,15) | -32.89 mg/dL | Standard Deviation 20.294 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 7 (n=8,9,9,9,7,15) | -30.22 mg/dL | Standard Deviation 16.672 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 13 (n=8,9,9,9,7,15) | -30.89 mg/dL | Standard Deviation 19.548 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 4 (n=9,9,9,9,8,16) | -19.67 mg/dL | Standard Deviation 20.899 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 3 (n=9,9,9,9,9,16) | -13.22 mg/dL | Standard Deviation 15.571 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 15 (n=8,9,9,9,7,15) | -44.11 mg/dL | Standard Deviation 19.586 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 12 (n=8,9,9,9,7,15) | -32.22 mg/dL | Standard Deviation 17.88 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 5 (n=9,9,9,9,9,16) | -26.56 mg/dL | Standard Deviation 21.03 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (n=9,9,9,9,9,16) | 193.67 mg/dL | Standard Deviation 45.695 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 10 (n=8,9,9,9,7,15) | -37.11 mg/dL | Standard Deviation 19.877 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 8 (n=8,9,9,9,7,15) | -24.11 mg/dL | Standard Deviation 19.934 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 2 (n=9,9,9,9,9,16) | -1.78 mg/dL | Standard Deviation 14.507 |
| PF-04937319 100 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 14 (n=8,9,9,9,7,15) | -43.78 mg/dL | Standard Deviation 22.725 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 7 (n=8,9,9,9,7,15) | -43.71 mg/dL | Standard Deviation 18.117 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 15 (n=8,9,9,9,7,15) | -40.57 mg/dL | Standard Deviation 25.553 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 9 (n=8,9,9,9,7,15) | -38.00 mg/dL | Standard Deviation 19.502 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 5 (n=9,9,9,9,9,16) | -30.33 mg/dL | Standard Deviation 22.17 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 10 (n=8,9,9,9,7,15) | -34.29 mg/dL | Standard Deviation 24.452 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 4 (n=9,9,9,9,8,16) | -42.88 mg/dL | Standard Deviation 20.972 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (n=9,9,9,9,9,16) | 162.33 mg/dL | Standard Deviation 50.269 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 11 (n=8,9,9,9,7,15) | -38.57 mg/dL | Standard Deviation 22.24 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 3 (n=9,9,9,9,9,16) | -32.78 mg/dL | Standard Deviation 17.527 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 12 (n=8,9,9,9,7,15) | -43.57 mg/dL | Standard Deviation 26.576 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 13 (n=8,9,9,9,7,15) | -39.71 mg/dL | Standard Deviation 22.706 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 2 (n=9,9,9,9,9,16) | -23.44 mg/dL | Standard Deviation 18.662 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 14 (n=8,9,9,9,7,15) | -41.86 mg/dL | Standard Deviation 22.386 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 8 (n=8,9,9,9,7,15) | -31.71 mg/dL | Standard Deviation 20.155 |
| PF-04937319 300 mg | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 6 (n=9,9,9,9,7,15) | -43.00 mg/dL | Standard Deviation 15.61 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 6 (n=9,9,9,9,7,15) | -8.27 mg/dL | Standard Deviation 12.708 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 13 (n=8,9,9,9,7,15) | -12.27 mg/dL | Standard Deviation 18.718 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 4 (n=9,9,9,9,8,16) | -4.13 mg/dL | Standard Deviation 18.722 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 8 (n=8,9,9,9,7,15) | -4.93 mg/dL | Standard Deviation 16.434 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 14 (n=8,9,9,9,7,15) | -11.80 mg/dL | Standard Deviation 16.545 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 10 (n=8,9,9,9,7,15) | -6.20 mg/dL | Standard Deviation 10.544 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Baseline (n=9,9,9,9,9,16) | 172.44 mg/dL | Standard Deviation 42.527 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 15 (n=8,9,9,9,7,15) | -11.47 mg/dL | Standard Deviation 17.916 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 9 (n=8,9,9,9,7,15) | -2.80 mg/dL | Standard Deviation 15.857 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 5 (n=9,9,9,9,9,16) | -14.06 mg/dL | Standard Deviation 21.402 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 12 (n=8,9,9,9,7,15) | -7.73 mg/dL | Standard Deviation 17.91 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 3 (n=9,9,9,9,9,16) | -7.81 mg/dL | Standard Deviation 16.885 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 2 (n=9,9,9,9,9,16) | 0.94 mg/dL | Standard Deviation 12.588 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 7 (n=8,9,9,9,7,15) | -5.60 mg/dL | Standard Deviation 12.704 |
| Placebo | Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 | Change at Day 11 (n=8,9,9,9,7,15) | -5.73 mg/dL | Standard Deviation 19.374 |
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -10.50 mg/dL | Standard Deviation 5.78 |
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -7.63 mg/dL | Standard Deviation 4.21 |
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -4.00 mg/dL | Standard Deviation 2.65 |
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -4.89 mg/dL | Standard Deviation 3.98 |
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -11.0 mg/dL | Standard Deviation 5.1 |
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -3.56 mg/dL | Standard Deviation 4.1 |
| PF-04937319 10 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 48.11 mg/dL | Standard Deviation 10.96 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -5.78 mg/dL | Standard Deviation 10.59 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 43.33 mg/dL | Standard Deviation 9.51 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -3.67 mg/dL | Standard Deviation 6.36 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -3.44 mg/dL | Standard Deviation 5.98 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -5.78 mg/dL | Standard Deviation 7.61 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -5.22 mg/dL | Standard Deviation 6.5 |
| PF-04937319 30 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -4.33 mg/dL | Standard Deviation 7.73 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | 1.33 mg/dL | Standard Deviation 6.75 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | 0.00 mg/dL | Standard Deviation 5.15 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -3.22 mg/dL | Standard Deviation 7.24 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 1.22 mg/dL | Standard Deviation 5.7 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | 1.00 mg/dL | Standard Deviation 4.66 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 46.44 mg/dL | Standard Deviation 11.51 |
| PF-04937319 50 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -1.56 mg/dL | Standard Deviation 5.7 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -4.22 mg/dL | Standard Deviation 4.12 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -4.44 mg/dL | Standard Deviation 6.98 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -3.11 mg/dL | Standard Deviation 3.69 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -4.56 mg/dL | Standard Deviation 4.07 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -4.44 mg/dL | Standard Deviation 4.93 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -4.44 mg/dL | Standard Deviation 3.21 |
| PF-04937319 100 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 43.89 mg/dL | Standard Deviation 13.66 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -0.67 mg/dL | Standard Deviation 7.07 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 1.14 mg/dL | Standard Deviation 4.49 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -0.86 mg/dL | Standard Deviation 4.38 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 49.44 mg/dL | Standard Deviation 14.05 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | 1.00 mg/dL | Standard Deviation 3.79 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -2.29 mg/dL | Standard Deviation 4.07 |
| PF-04937319 300 mg | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -2.43 mg/dL | Standard Deviation 2.64 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -3.50 mg/dL | Standard Deviation 6.86 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -3.36 mg/dL | Standard Deviation 9.04 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -6.93 mg/dL | Standard Deviation 9.52 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -3.88 mg/dL | Standard Deviation 8.02 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -5.00 mg/dL | Standard Deviation 7.99 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -6.20 mg/dL | Standard Deviation 7.8 |
| Placebo | Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 48.94 mg/dL | Standard Deviation 9.33 |
Change From Baseline in Lactate Level at Day 6 and 14
Baseline value was collected at 0 hour on Day 1 for lactate.
Time frame: Baseline (Day 1), Day 6 and 14
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 6 (n=9,9,9,9,7,15) | -2.44 mg/dL | Standard Deviation 7.95 |
| PF-04937319 10 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (n=9,9,9,9,9,16) | 17.64 mg/dL | Standard Deviation 5.14 |
| PF-04937319 10 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 14 (n=8,9,9,9,7,15) | 0.21 mg/dL | Standard Deviation 3.07 |
| PF-04937319 30 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 6 (n=9,9,9,9,7,15) | 1.02 mg/dL | Standard Deviation 1.77 |
| PF-04937319 30 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (n=9,9,9,9,9,16) | 10.17 mg/dL | Standard Deviation 3.07 |
| PF-04937319 30 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 14 (n=8,9,9,9,7,15) | -0.09 mg/dL | Standard Deviation 2.02 |
| PF-04937319 50 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 6 (n=9,9,9,9,7,15) | -2.08 mg/dL | Standard Deviation 7.14 |
| PF-04937319 50 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (n=9,9,9,9,9,16) | 14.14 mg/dL | Standard Deviation 7.82 |
| PF-04937319 50 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 14 (n=8,9,9,9,7,15) | -3.88 mg/dL | Standard Deviation 6.63 |
| PF-04937319 100 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 6 (n=9,9,9,9,7,15) | -6.08 mg/dL | Standard Deviation 10.72 |
| PF-04937319 100 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (n=9,9,9,9,9,16) | 21.66 mg/dL | Standard Deviation 9.45 |
| PF-04937319 100 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 14 (n=8,9,9,9,7,15) | -6.97 mg/dL | Standard Deviation 10.42 |
| PF-04937319 300 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 6 (n=9,9,9,9,7,15) | 2.61 mg/dL | Standard Deviation 6.6 |
| PF-04937319 300 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (n=9,9,9,9,9,16) | 11.57 mg/dL | Standard Deviation 4.3 |
| PF-04937319 300 mg | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 14 (n=8,9,9,9,7,15) | 2.60 mg/dL | Standard Deviation 2.98 |
| Placebo | Change From Baseline in Lactate Level at Day 6 and 14 | Baseline (n=9,9,9,9,9,16) | 14.74 mg/dL | Standard Deviation 8.58 |
| Placebo | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 14 (n=8,9,9,9,7,15) | -2.59 mg/dL | Standard Deviation 8.67 |
| Placebo | Change From Baseline in Lactate Level at Day 6 and 14 | Change at Day 6 (n=9,9,9,9,7,15) | -1.45 mg/dL | Standard Deviation 9.27 |
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -17.13 mg/dL | Standard Deviation 21.14 |
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -8.78 mg/dL | Standard Deviation 23.21 |
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,8,9,9,7,16) | -6.22 mg/dL | Standard Deviation 24.4 |
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 116.67 mg/dL | Standard Deviation 37.41 |
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -19.22 mg/dL | Standard Deviation 22.22 |
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -17.88 mg/dL | Standard Deviation 22.22 |
| PF-04937319 10 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -19.00 mg/dL | Standard Deviation 24.94 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -22.44 mg/dL | Standard Deviation 16.49 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -11.44 mg/dL | Standard Deviation 16.84 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,8,9,9,7,16) | -10.38 mg/dL | Standard Deviation 15.15 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -5.89 mg/dL | Standard Deviation 19.37 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 133.56 mg/dL | Standard Deviation 43.47 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -20.44 mg/dL | Standard Deviation 22.32 |
| PF-04937319 30 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -15.00 mg/dL | Standard Deviation 14.11 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -13.67 mg/dL | Standard Deviation 14.74 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 123.44 mg/dL | Standard Deviation 35.72 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -6.89 mg/dL | Standard Deviation 15.26 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -30.89 mg/dL | Standard Deviation 14.08 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -19.89 mg/dL | Standard Deviation 14.68 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -20.22 mg/dL | Standard Deviation 16.75 |
| PF-04937319 50 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,8,9,9,7,16) | -27.11 mg/dL | Standard Deviation 22.05 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 130.67 mg/dL | Standard Deviation 33.83 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -6.67 mg/dL | Standard Deviation 19.46 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -2.33 mg/dL | Standard Deviation 22.11 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -7.89 mg/dL | Standard Deviation 17.92 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -11.56 mg/dL | Standard Deviation 17.92 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -0.67 mg/dL | Standard Deviation 16.86 |
| PF-04937319 100 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,8,9,9,7,16) | -19.78 mg/dL | Standard Deviation 22.97 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -11.00 mg/dL | Standard Deviation 23.51 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,8,9,9,7,16) | -17.43 mg/dL | Standard Deviation 16.7 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -0.29 mg/dL | Standard Deviation 38.98 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 96.11 mg/dL | Standard Deviation 37.88 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -9.57 mg/dL | Standard Deviation 35.69 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -3.86 mg/dL | Standard Deviation 38.21 |
| PF-04937319 300 mg | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -1.00 mg/dL | Standard Deviation 38.18 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | 5.79 mg/dL | Standard Deviation 27.5 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | 4.80 mg/dL | Standard Deviation 30.59 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -3.63 mg/dL | Standard Deviation 14.8 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | 2.73 mg/dL | Standard Deviation 20.35 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 102.44 mg/dL | Standard Deviation 31.64 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,8,9,9,7,16) | -2.25 mg/dL | Standard Deviation 23.61 |
| Placebo | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 5.07 mg/dL | Standard Deviation 24.99 |
Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -30.00 mg/dL | Standard Deviation 24.51 |
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -19.44 mg/dL | Standard Deviation 25.73 |
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -26.38 mg/dL | Standard Deviation 26.72 |
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 200.56 mg/dL | Standard Deviation 34.32 |
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -31.50 mg/dL | Standard Deviation 21.08 |
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -19.11 mg/dL | Standard Deviation 20.95 |
| PF-04937319 10 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -24.00 mg/dL | Standard Deviation 17.21 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -25.11 mg/dL | Standard Deviation 19.47 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -14.67 mg/dL | Standard Deviation 14.4 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -12.44 mg/dL | Standard Deviation 24.7 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -9.33 mg/dL | Standard Deviation 13.46 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -29.11 mg/dL | Standard Deviation 14.42 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -22.11 mg/dL | Standard Deviation 13.6 |
| PF-04937319 30 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 207.33 mg/dL | Standard Deviation 41.11 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -29.44 mg/dL | Standard Deviation 27.13 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -14.22 mg/dL | Standard Deviation 16.93 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -20.78 mg/dL | Standard Deviation 19.39 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -30.89 mg/dL | Standard Deviation 17.41 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 205.00 mg/dL | Standard Deviation 50.52 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -27.44 mg/dL | Standard Deviation 17.08 |
| PF-04937319 50 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -29.11 mg/dL | Standard Deviation 20.26 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -16.33 mg/dL | Standard Deviation 18.33 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -33.56 mg/dL | Standard Deviation 40.73 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -12.11 mg/dL | Standard Deviation 24.49 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -11.33 mg/dL | Standard Deviation 21.17 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 213.22 mg/dL | Standard Deviation 53.38 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -15.11 mg/dL | Standard Deviation 20.76 |
| PF-04937319 100 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -24.22 mg/dL | Standard Deviation 25.73 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -11.56 mg/dL | Standard Deviation 31.13 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 170.22 mg/dL | Standard Deviation 41.37 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -2.29 mg/dL | Standard Deviation 41.43 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | 1.29 mg/dL | Standard Deviation 41.63 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | 1.86 mg/dL | Standard Deviation 45.05 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | 0.00 mg/dL | Standard Deviation 42.9 |
| PF-04937319 300 mg | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -15.29 mg/dL | Standard Deviation 8.24 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -5.50 mg/dL | Standard Deviation 29.57 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -6.47 mg/dL | Standard Deviation 26.19 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 0.33 mg/dL | Standard Deviation 30 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -7.50 mg/dL | Standard Deviation 18.4 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 181.94 mg/dL | Standard Deviation 34.45 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -1.43 mg/dL | Standard Deviation 32.9 |
| Placebo | Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -6.60 mg/dL | Standard Deviation 37.37 |
Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Time frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -41.22 mg/dL | Standard Deviation 73.73 |
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -19.25 mg/dL | Standard Deviation 76.2 |
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -5.89 mg/dL | Standard Deviation 82.19 |
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | 13.25 mg/dL | Standard Deviation 108.99 |
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 178.89 mg/dL | Standard Deviation 63.21 |
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -32.00 mg/dL | Standard Deviation 70.4 |
| PF-04937319 10 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -16.88 mg/dL | Standard Deviation 58.15 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | 1.67 mg/dL | Standard Deviation 63.16 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 1.78 mg/dL | Standard Deviation 66.28 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 152.33 mg/dL | Standard Deviation 43.88 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -1.33 mg/dL | Standard Deviation 65.02 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -4.44 mg/dL | Standard Deviation 65.79 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -6.67 mg/dL | Standard Deviation 80.27 |
| PF-04937319 30 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | 38.78 mg/dL | Standard Deviation 163.3 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -44.44 mg/dL | Standard Deviation 45.88 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | 4.56 mg/dL | Standard Deviation 73.52 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -6.44 mg/dL | Standard Deviation 59.39 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -36.22 mg/dL | Standard Deviation 50.27 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -37.33 mg/dL | Standard Deviation 48.75 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -40.44 mg/dL | Standard Deviation 50.85 |
| PF-04937319 50 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 175.56 mg/dL | Standard Deviation 53.32 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | -25.44 mg/dL | Standard Deviation 59.99 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 192.78 mg/dL | Standard Deviation 91.62 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -29.00 mg/dL | Standard Deviation 62.9 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | -13.56 mg/dL | Standard Deviation 51.83 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -40.33 mg/dL | Standard Deviation 55.72 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -35.33 mg/dL | Standard Deviation 53.61 |
| PF-04937319 100 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | -45.44 mg/dL | Standard Deviation 120.43 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | 23.57 mg/dL | Standard Deviation 50.04 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 30.71 mg/dL | Standard Deviation 43.77 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | 22.29 mg/dL | Standard Deviation 57.79 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | 13.14 mg/dL | Standard Deviation 51.5 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | 0.22 mg/dL | Standard Deviation 42.4 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 123.33 mg/dL | Standard Deviation 47.89 |
| PF-04937319 300 mg | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | 15.57 mg/dL | Standard Deviation 38.25 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Baseline (n=9,9,9,9,9,16) | 152.31 mg/dL | Standard Deviation 70.46 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 10 (n=8,9,9,9,7,15) | 2.13 mg/dL | Standard Deviation 46.04 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 3 (n=9,9,9,9,9,16) | 0.88 mg/dL | Standard Deviation 47.31 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 6 (n=9,9,9,9,7,15) | -14.67 mg/dL | Standard Deviation 51.85 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 16 (n=8,9,9,9,7,14) | -19.07 mg/dL | Standard Deviation 47.96 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Day 14 (n=8,9,9,9,7,15) | -21.67 mg/dL | Standard Deviation 44.03 |
| Placebo | Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up | Change at Follow-up (n=9,9,9,9,7,16) | 1.94 mg/dL | Standard Deviation 52.43 |
Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14
Percent change from baseline in 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.
Time frame: -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 and 14 (fasted condition)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | -2.36 percent change | Standard Deviation 10.17 |
| PF-04937319 10 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 8.66 percent change | Standard Deviation 11.069 |
| PF-04937319 30 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 8.53 percent change | Standard Deviation 13.383 |
| PF-04937319 30 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 13.49 percent change | Standard Deviation 14.403 |
| PF-04937319 50 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 12.65 percent change | Standard Deviation 9.974 |
| PF-04937319 50 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 16.51 percent change | Standard Deviation 27.962 |
| PF-04937319 100 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 2.37 percent change | Standard Deviation 12.421 |
| PF-04937319 100 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | -1.44 percent change | Standard Deviation 14.463 |
| PF-04937319 300 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 16.34 percent change | Standard Deviation 8.94 |
| PF-04937319 300 mg | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 22.50 percent change | Standard Deviation 14.809 |
| Placebo | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | -1.43 percent change | Standard Deviation 9.488 |
| Placebo | Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 1.80 percent change | Standard Deviation 16.722 |
Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14
Percent change from baseline in 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.
Time frame: -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 and 14 (fasted condition)
Population: PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 10 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | -2.22 percent change | Standard Deviation 17.843 |
| PF-04937319 10 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 15.77 percent change | Standard Deviation 21.452 |
| PF-04937319 30 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 13.24 percent change | Standard Deviation 22.221 |
| PF-04937319 30 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 17.98 percent change | Standard Deviation 26.499 |
| PF-04937319 50 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 24.11 percent change | Standard Deviation 13.772 |
| PF-04937319 50 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 30.86 percent change | Standard Deviation 41.063 |
| PF-04937319 100 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 4.41 percent change | Standard Deviation 17.47 |
| PF-04937319 100 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 0.38 percent change | Standard Deviation 21.14 |
| PF-04937319 300 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | 18.10 percent change | Standard Deviation 17.059 |
| PF-04937319 300 mg | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 39.23 percent change | Standard Deviation 26.876 |
| Placebo | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 1 (n=9,9,9,9,9,16) | -2.92 percent change | Standard Deviation 15.768 |
| Placebo | Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14 | Percent Change at Day 14 (n=8,9,9,9,7,15) | 7.62 percent change | Standard Deviation 26.034 |