Type 2 Diabetes Mellitus
Conditions
Keywords
Phase 1, bioavailability, type 2 diabetes mellitus, PF-04937319
Brief summary
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
Interventions
DRUGPF-04937319 IR MST
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
DRUGPF-04937319 MR 1
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
DRUGPF-04937319 MR 2
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
DRUGPF-04937319 MR 3
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs)
Exclusion criteria
* Patients with cardiovascular event within 6 months of screening * Patients with diabetic complications * Female subjects who are pregnant or planning to become pregnant * Subjects with unstable medical conditions (eg, hypertension)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. |
| Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose | MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | — |
| PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | — |
| Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose. |
| Maximum Observed PF-04937319 Plasma Concentration (Cmax) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | — |
| Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Terminal Elimination Half-Life (t1/2) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | t1/2 is the time measured for the plasma concentration to decrease by one half. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to 28 days after last study drug administration in Period 4 | An AE was any untoward medical occurrence in a participant who received study drug. 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 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. |
| Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | — |
| PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5) | 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose | — |
Countries
United States
Participant flow
Pre-assignment details
Prior to being enrolled in the 4 period crossover, participants were required to complete an open-label, sponsor-provided metformin period. 42 participants started the metformin period and of those 42 participants, 39 were enrolled in the 4 period crossover and received at least 1 dose PF-04937319.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received at least 1 dose of PF-04937319. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Open-Label Run-In | Withdrawal by Subject | 3 | 0 | 0 | 0 | 0 |
| Second Intervention Period | Insufficient Clinical Response | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 7.1 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 20 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 42 | 11 / 38 | 6 / 39 | 10 / 39 | 5 / 38 |
| serious Total, serious adverse events | 0 / 42 | 0 / 38 | 0 / 39 | 0 / 39 | 0 / 38 |
Outcome results
Primary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | 10690 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 26 |
| PF-04937319 250 mg MR1 | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | 3187 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 59 |
| PF-04937319 300 mg MR2 | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | 2725 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 35 |
| PF-04937319 330 mg MR3 | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] | 3430 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 37 |
90% CI: [28.09, 34.8]
90% CI: [23.11, 28.27]
90% CI: [28.93, 35.49]
Primary
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
Population: The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04937319 150+100 mg IR | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Observed (n=36,33,32,35) | 159.47 milligrams per deciliter (mg/dL) | Standard Deviation 42.949 |
| PF-04937319 150+100 mg IR | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Change From Reference (36,33,32,35) | NA milligrams per deciliter (mg/dL) | — |
| PF-04937319 250 mg MR1 | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Change From Reference (36,33,32,35) | 15.55 milligrams per deciliter (mg/dL) | Standard Deviation 19.358 |
| PF-04937319 250 mg MR1 | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Observed (n=36,33,32,35) | 176.24 milligrams per deciliter (mg/dL) | Standard Deviation 42.648 |
| PF-04937319 300 mg MR2 | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Observed (n=36,33,32,35) | 170.85 milligrams per deciliter (mg/dL) | Standard Deviation 38.928 |
| PF-04937319 300 mg MR2 | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Change From Reference (36,33,32,35) | 15.96 milligrams per deciliter (mg/dL) | Standard Deviation 17.122 |
| PF-04937319 330 mg MR3 | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Observed (n=36,33,32,35) | 180.47 milligrams per deciliter (mg/dL) | Standard Deviation 50.099 |
| PF-04937319 330 mg MR3 | Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1 | Change From Reference (36,33,32,35) | 20.15 milligrams per deciliter (mg/dL) | Standard Deviation 20.005 |
p-value: 180% CI: [11.39, 20.06]Mixed Models Analysis
p-value: 180% CI: [11.93, 20.7]Mixed Models Analysis
p-value: 180% CI: [16.13, 24.62]Mixed Models Analysis
Secondary
Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) | 10560 ng*hr/mL | Geometric Coefficient of Variation 26 |
| PF-04937319 250 mg MR1 | Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) | 3287 ng*hr/mL | Geometric Coefficient of Variation 55 |
| PF-04937319 300 mg MR2 | Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) | 2644 ng*hr/mL | Geometric Coefficient of Variation 34 |
| PF-04937319 330 mg MR3 | Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) | 3369 ng*hr/mL | Geometric Coefficient of Variation 34 |
90% CI: [28.28, 34.1]
90% CI: [22.73, 27.4]
90% CI: [28.86, 34.81]
Secondary
Maximum Observed PF-04937319 Plasma Concentration (Cmax)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | Maximum Observed PF-04937319 Plasma Concentration (Cmax) | 641.2 ng/mL | Geometric Coefficient of Variation 22 |
| PF-04937319 250 mg MR1 | Maximum Observed PF-04937319 Plasma Concentration (Cmax) | 161.8 ng/mL | Geometric Coefficient of Variation 37 |
| PF-04937319 300 mg MR2 | Maximum Observed PF-04937319 Plasma Concentration (Cmax) | 171.3 ng/mL | Geometric Coefficient of Variation 24 |
| PF-04937319 330 mg MR3 | Maximum Observed PF-04937319 Plasma Concentration (Cmax) | 236.2 ng/mL | Geometric Coefficient of Variation 24 |
90% CI: [23.28, 27.31]
90% CI: [24.36, 28.57]
90% CI: [34.09, 40.02]
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug. 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 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to 28 days after last study drug administration in Period 4
Population: The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04937319 150+100 mg IR | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 2 participants |
| PF-04937319 150+100 mg IR | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 250 mg MR1 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 16 participants |
| PF-04937319 250 mg MR1 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 300 mg MR2 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 11 participants |
| PF-04937319 300 mg MR2 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 330 mg MR3 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04937319 330 mg MR3 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 16 participants |
| PF-04937319 330 mg MR3 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 10 participants |
| PF-04937319 330 mg MR3 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 participants |
Secondary
PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16) | 324.7 ng/mL | Geometric Coefficient of Variation 34 |
| PF-04937319 250 mg MR1 | PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16) | 74.49 ng/mL | Geometric Coefficient of Variation 57 |
| PF-04937319 300 mg MR2 | PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16) | 58.88 ng/mL | Geometric Coefficient of Variation 37 |
| PF-04937319 330 mg MR3 | PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16) | 77.92 ng/mL | Geometric Coefficient of Variation 37 |
Secondary
PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24) | 171.1 ng/dL | Geometric Coefficient of Variation 37 |
| PF-04937319 250 mg MR1 | PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24) | 56.04 ng/dL | Geometric Coefficient of Variation 64 |
| PF-04937319 300 mg MR2 | PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24) | 39.38 ng/dL | Geometric Coefficient of Variation 52 |
| PF-04937319 330 mg MR3 | PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24) | 48.17 ng/dL | Geometric Coefficient of Variation 47 |
Secondary
PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5) | 413.2 ng/mL | Geometric Coefficient of Variation 26 |
| PF-04937319 250 mg MR1 | PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5) | 124.3 ng/mL | Geometric Coefficient of Variation 43 |
| PF-04937319 300 mg MR2 | PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5) | 154.3 ng/mL | Geometric Coefficient of Variation 29 |
| PF-04937319 330 mg MR3 | PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5) | 202.1 ng/mL | Geometric Coefficient of Variation 30 |
Secondary
Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) | 3.748 ratio | Geometric Coefficient of Variation 33 |
| PF-04937319 250 mg MR1 | Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) | 2.887 ratio | Geometric Coefficient of Variation 49 |
| PF-04937319 300 mg MR2 | Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) | 4.350 ratio | Geometric Coefficient of Variation 48 |
| PF-04937319 330 mg MR3 | Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) | 4.903 ratio | Geometric Coefficient of Variation 43 |
Secondary
Terminal Elimination Half-Life (t1/2)
t1/2 is the time measured for the plasma concentration to decrease by one half.
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04937319 150+100 mg IR | Terminal Elimination Half-Life (t1/2) | 8.648 hour | Standard Deviation 2.7801 |
| PF-04937319 250 mg MR1 | Terminal Elimination Half-Life (t1/2) | 12.10 hour | Standard Deviation 5.5922 |
| PF-04937319 300 mg MR2 | Terminal Elimination Half-Life (t1/2) | 13.52 hour | Standard Deviation 6.9657 |
| PF-04937319 330 mg MR3 | Terminal Elimination Half-Life (t1/2) | 12.62 hour | Standard Deviation 6.1783 |
Secondary
Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)
Time frame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
Population: The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04937319 150+100 mg IR | Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) | 8.00 hours |
| PF-04937319 250 mg MR1 | Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) | 6.00 hours |
| PF-04937319 300 mg MR2 | Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) | 5.00 hours |
| PF-04937319 330 mg MR3 | Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) | 5.00 hours |