Trial Outcomes & Findings for Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes (NCT NCT01272804)
NCT ID: NCT01272804
Last Updated: 2017-02-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)
Results posted on
2017-02-01
Participant Flow
Participant milestones
| Measure |
PF-04937319 10 mg
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
9
|
16
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
9
|
7
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
PF-04937319 10 mg
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
49.4 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
54.2 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
51.4 years
STANDARD_DEVIATION 10.6 • n=483 Participants
|
56.4 years
STANDARD_DEVIATION 5.8 • n=36 Participants
|
57.3 years
STANDARD_DEVIATION 5.8 • n=10 Participants
|
54.4 years
STANDARD_DEVIATION 7.7 • n=115 Participants
|
|
Gender
Female
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Gender
Male
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
6 participants
|
5 participants
|
0 participants
|
3 participants
|
8 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) On Day 1
|
38.22 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
69.49 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
119.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
245.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
449.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) On Day 6
|
57.73 ng/mL
Geometric Coefficient of Variation 17
|
122.3 ng/mL
Geometric Coefficient of Variation 17
|
234.1 ng/mL
Geometric Coefficient of Variation 24
|
421.5 ng/mL
Geometric Coefficient of Variation 31
|
970.6 ng/mL
Geometric Coefficient of Variation 35
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1
|
3.00 hour
Interval 1.5 to 8.0
|
3.00 hour
Interval 1.5 to 8.0
|
3.00 hour
Interval 2.95 to 5.0
|
3.00 hour
Interval 3.0 to 5.0
|
3.00 hour
Interval 1.5 to 8.0
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6
|
1.50 hour
Interval 1.5 to 5.05
|
1.50 hour
Interval 1.5 to 5.0
|
1.50 hour
Interval 1.5 to 8.0
|
1.50 hour
Interval 1.5 to 5.0
|
1.50 hour
Interval 0.5 to 5.07
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
867.7 nanogram*hour per milliliter
Geometric Coefficient of Variation 21
|
1456 nanogram*hour per milliliter
Geometric Coefficient of Variation 48
|
2749 nanogram*hour per milliliter
Geometric Coefficient of Variation 38
|
6034 nanogram*hour per milliliter
Geometric Coefficient of Variation 40
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14
|
51.09 ng/mL
Geometric Coefficient of Variation 27
|
79.30 ng/mL
Geometric Coefficient of Variation 31
|
171.3 ng/mL
Geometric Coefficient of Variation 36
|
251.5 ng/mL
Geometric Coefficient of Variation 44
|
555.9 ng/mL
Geometric Coefficient of Variation 44
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14
|
3.00 hour
Interval 1.5 to 3.02
|
3.00 hour
Interval 1.5 to 8.0
|
3.00 hour
Interval 3.0 to 8.0
|
3.00 hour
Interval 3.0 to 8.0
|
3.00 hour
Interval 3.0 to 8.0
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
928.7 nanogram*hour per milliliter
Geometric Coefficient of Variation 23
|
1889 nanogram*hour per milliliter
Geometric Coefficient of Variation 52
|
3167 nanogram*hour per milliliter
Geometric Coefficient of Variation 40
|
7446 nanogram*hour per milliliter
Geometric Coefficient of Variation 42
|
—
|
PRIMARY outcome
Timeframe: 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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2) on Day 14
|
6.563 hour
Standard Deviation 0.77897
|
6.884 hour
Standard Deviation 1.9264
|
6.348 hour
Standard Deviation 1.4271
|
6.960 hour
Standard Deviation 1.0358
|
8.479 hour
Standard Deviation 2.4173
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14
|
1.380 ng/mL
Geometric Coefficient of Variation 83
|
10.56 ng/mL
Geometric Coefficient of Variation 43
|
22.73 ng/mL
Geometric Coefficient of Variation 103
|
41.68 ng/mL
Geometric Coefficient of Variation 64
|
129.8 ng/mL
Geometric Coefficient of Variation 62
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) through 24 hours post-dose on Day 14Population: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=7 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=5 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14
|
0.3904 percentage of dose
Standard Deviation 0.11901
|
0.3533 percentage of dose
Standard Deviation 0.20183
|
0.6463 percentage of dose
Standard Deviation 0.56717
|
0.5380 percentage of dose
Standard Deviation 0.34593
|
0.4294 percentage of dose
Standard Deviation 0.44676
|
—
|
PRIMARY outcome
Timeframe: 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.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) on Day 14
|
21.86 liter per hour
Geometric Coefficient of Variation 25
|
32.32 liter per hour
Geometric Coefficient of Variation 23
|
26.48 liter per hour
Geometric Coefficient of Variation 34
|
31.56 liter per hour
Geometric Coefficient of Variation 37
|
40.29 liter per hour
Geometric Coefficient of Variation 43
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) on Day 14
|
205.3 liter
Geometric Coefficient of Variation 20
|
311.6 liter
Geometric Coefficient of Variation 32
|
236.7 liter
Geometric Coefficient of Variation 27
|
314.0 liter
Geometric Coefficient of Variation 28
|
475.2 liter
Geometric Coefficient of Variation 48
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio for AUCtau (Rac)
|
1.204 ratio
Geometric Coefficient of Variation 22
|
1.069 ratio
Geometric Coefficient of Variation 15
|
1.296 ratio
Geometric Coefficient of Variation 24
|
1.152 ratio
Geometric Coefficient of Variation 22
|
1.118 ratio
Geometric Coefficient of Variation 40
|
—
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=7 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio for Cmax (Rac, Cmax)
|
1.414 ratio
Geometric Coefficient of Variation 41
|
1.141 ratio
Geometric Coefficient of Variation 28
|
1.437 ratio
Geometric Coefficient of Variation 17
|
1.026 ratio
Geometric Coefficient of Variation 25
|
1.080 ratio
Geometric Coefficient of Variation 40
|
—
|
PRIMARY outcome
Timeframe: -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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
-2.67 percent change
Standard Deviation 6.670
|
6.41 percent change
Standard Deviation 14.532
|
-12.11 percent change
Standard Deviation 14.225
|
-12.29 percent change
Standard Deviation 13.711
|
-3.71 percent change
Standard Deviation 10.848
|
PRIMARY outcome
Timeframe: -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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=8 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=6 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=15 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
-4.91 percent change
Standard Deviation 16.601
|
-4.11 percent change
Standard Deviation 17.321
|
-26.83 percent change
Standard Deviation 21.054
|
-11.37 percent change
Standard Deviation 15.205
|
-2.86 percent change
Standard Deviation 12.103
|
SECONDARY outcome
Timeframe: -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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
13.24 percent change
Standard Deviation 22.221
|
24.11 percent change
Standard Deviation 13.772
|
4.41 percent change
Standard Deviation 17.470
|
18.10 percent change
Standard Deviation 17.059
|
-2.92 percent change
Standard Deviation 15.768
|
|
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
|
17.98 percent change
Standard Deviation 26.499
|
30.86 percent change
Standard Deviation 41.063
|
0.38 percent change
Standard Deviation 21.140
|
39.23 percent change
Standard Deviation 26.876
|
7.62 percent change
Standard Deviation 26.034
|
SECONDARY outcome
Timeframe: -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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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 10.170
|
8.53 percent change
Standard Deviation 13.383
|
12.65 percent change
Standard Deviation 9.974
|
2.37 percent change
Standard Deviation 12.421
|
16.34 percent change
Standard Deviation 8.940
|
-1.43 percent change
Standard Deviation 9.488
|
|
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
|
13.49 percent change
Standard Deviation 14.403
|
16.51 percent change
Standard Deviation 27.962
|
-1.44 percent change
Standard Deviation 14.463
|
22.50 percent change
Standard Deviation 14.809
|
1.80 percent change
Standard Deviation 16.722
|
SECONDARY outcome
Timeframe: -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 14Population: 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.
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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
188.83 mg/dL
Standard Deviation 48.992
|
195.78 mg/dL
Standard Deviation 37.871
|
205.38 mg/dL
Standard Deviation 44.632
|
170.95 mg/dL
Standard Deviation 51.465
|
189.07 mg/dL
Standard Deviation 39.131
|
|
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
|
-5.24 mg/dL
Standard Deviation 6.421
|
8.72 mg/dL
Standard Deviation 15.071
|
-1.90 mg/dL
Standard Deviation 21.784
|
-23.26 mg/dL
Standard Deviation 19.189
|
3.04 mg/dL
Standard Deviation 17.611
|
|
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
|
-6.35 mg/dL
Standard Deviation 22.496
|
9.80 mg/dL
Standard Deviation 30.359
|
-32.36 mg/dL
Standard Deviation 24.121
|
-47.19 mg/dL
Standard Deviation 25.752
|
3.92 mg/dL
Standard Deviation 17.068
|
|
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
|
-16.45 mg/dL
Standard Deviation 27.709
|
-14.79 mg/dL
Standard Deviation 33.687
|
-48.87 mg/dL
Standard Deviation 27.216
|
-34.15 mg/dL
Standard Deviation 24.596
|
-7.48 mg/dL
Standard Deviation 21.703
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15Population: 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.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
-9.44 mg/dL
Standard Deviation 16.001
|
-13.78 mg/dL
Standard Deviation 28.900
|
-19.67 mg/dL
Standard Deviation 20.899
|
-42.88 mg/dL
Standard Deviation 20.972
|
-4.13 mg/dL
Standard Deviation 18.722
|
|
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
|
-9.89 mg/dL
Standard Deviation 15.358
|
-22.56 mg/dL
Standard Deviation 29.560
|
-26.56 mg/dL
Standard Deviation 21.030
|
-30.33 mg/dL
Standard Deviation 22.170
|
-14.06 mg/dL
Standard Deviation 21.402
|
|
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
|
-22.11 mg/dL
Standard Deviation 20.709
|
-9.78 mg/dL
Standard Deviation 42.825
|
-24.78 mg/dL
Standard Deviation 17.817
|
-38.00 mg/dL
Standard Deviation 19.502
|
-2.80 mg/dL
Standard Deviation 15.857
|
|
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 28.540
|
-22.56 mg/dL
Standard Deviation 22.490
|
-18.11 mg/dL
Standard Deviation 39.810
|
-32.89 mg/dL
Standard Deviation 20.294
|
-38.57 mg/dL
Standard Deviation 22.240
|
-5.73 mg/dL
Standard Deviation 19.374
|
|
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
|
-18.56 mg/dL
Standard Deviation 28.183
|
-16.89 mg/dL
Standard Deviation 41.870
|
-32.22 mg/dL
Standard Deviation 17.880
|
-43.57 mg/dL
Standard Deviation 26.576
|
-7.73 mg/dL
Standard Deviation 17.910
|
|
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
|
181.33 mg/dL
Standard Deviation 50.621
|
190.11 mg/dL
Standard Deviation 34.505
|
193.67 mg/dL
Standard Deviation 45.695
|
162.33 mg/dL
Standard Deviation 50.269
|
172.44 mg/dL
Standard Deviation 42.527
|
|
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 10.840
|
-4.67 mg/dL
Standard Deviation 12.845
|
-6.78 mg/dL
Standard Deviation 25.430
|
-1.78 mg/dL
Standard Deviation 14.507
|
-23.44 mg/dL
Standard Deviation 18.662
|
0.94 mg/dL
Standard Deviation 12.588
|
|
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
|
-5.78 mg/dL
Standard Deviation 10.171
|
-18.78 mg/dL
Standard Deviation 27.124
|
-13.22 mg/dL
Standard Deviation 15.571
|
-32.78 mg/dL
Standard Deviation 17.527
|
-7.81 mg/dL
Standard Deviation 16.885
|
|
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 18.210
|
-16.33 mg/dL
Standard Deviation 17.804
|
-18.00 mg/dL
Standard Deviation 34.380
|
-29.11 mg/dL
Standard Deviation 16.027
|
-43.00 mg/dL
Standard Deviation 15.610
|
-8.27 mg/dL
Standard Deviation 12.708
|
|
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
|
-12.78 mg/dL
Standard Deviation 13.664
|
-14.44 mg/dL
Standard Deviation 37.270
|
-30.22 mg/dL
Standard Deviation 16.672
|
-43.71 mg/dL
Standard Deviation 18.117
|
-5.60 mg/dL
Standard Deviation 12.704
|
|
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
|
-8.56 mg/dL
Standard Deviation 20.415
|
-5.56 mg/dL
Standard Deviation 37.964
|
-24.11 mg/dL
Standard Deviation 19.934
|
-31.71 mg/dL
Standard Deviation 20.155
|
-4.93 mg/dL
Standard Deviation 16.434
|
|
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
|
-16.89 mg/dL
Standard Deviation 20.847
|
-16.33 mg/dL
Standard Deviation 32.427
|
-37.11 mg/dL
Standard Deviation 19.877
|
-34.29 mg/dL
Standard Deviation 24.452
|
-6.20 mg/dL
Standard Deviation 10.544
|
|
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
|
-23.44 mg/dL
Standard Deviation 23.807
|
-24.78 mg/dL
Standard Deviation 40.822
|
-30.89 mg/dL
Standard Deviation 19.548
|
-39.71 mg/dL
Standard Deviation 22.706
|
-12.27 mg/dL
Standard Deviation 18.718
|
|
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
|
-23.67 mg/dL
Standard Deviation 25.441
|
-26.56 mg/dL
Standard Deviation 39.768
|
-43.78 mg/dL
Standard Deviation 22.725
|
-41.86 mg/dL
Standard Deviation 22.386
|
-11.80 mg/dL
Standard Deviation 16.545
|
|
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
|
-21.44 mg/dL
Standard Deviation 26.034
|
-23.89 mg/dL
Standard Deviation 38.238
|
-44.11 mg/dL
Standard Deviation 19.586
|
-40.57 mg/dL
Standard Deviation 25.553
|
-11.47 mg/dL
Standard Deviation 17.916
|
SECONDARY outcome
Timeframe: 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.
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
152.33 mg/dL
Standard Deviation 43.88
|
175.56 mg/dL
Standard Deviation 53.32
|
192.78 mg/dL
Standard Deviation 91.62
|
123.33 mg/dL
Standard Deviation 47.89
|
152.31 mg/dL
Standard Deviation 70.46
|
|
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
|
1.67 mg/dL
Standard Deviation 63.16
|
-44.44 mg/dL
Standard Deviation 45.88
|
-25.44 mg/dL
Standard Deviation 59.99
|
0.22 mg/dL
Standard Deviation 42.40
|
0.88 mg/dL
Standard Deviation 47.31
|
|
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 70.40
|
-1.33 mg/dL
Standard Deviation 65.02
|
-40.44 mg/dL
Standard Deviation 50.85
|
-29.00 mg/dL
Standard Deviation 62.90
|
13.14 mg/dL
Standard Deviation 51.50
|
-14.67 mg/dL
Standard Deviation 51.85
|
|
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
|
1.78 mg/dL
Standard Deviation 66.28
|
-6.44 mg/dL
Standard Deviation 59.39
|
-13.56 mg/dL
Standard Deviation 51.83
|
30.71 mg/dL
Standard Deviation 43.77
|
2.13 mg/dL
Standard Deviation 46.04
|
|
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 76.20
|
-4.44 mg/dL
Standard Deviation 65.79
|
-37.33 mg/dL
Standard Deviation 48.75
|
-40.33 mg/dL
Standard Deviation 55.72
|
15.57 mg/dL
Standard Deviation 38.25
|
-21.67 mg/dL
Standard Deviation 44.03
|
|
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
|
-6.67 mg/dL
Standard Deviation 80.27
|
-36.22 mg/dL
Standard Deviation 50.27
|
-35.33 mg/dL
Standard Deviation 53.61
|
23.57 mg/dL
Standard Deviation 50.04
|
-19.07 mg/dL
Standard Deviation 47.96
|
|
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
|
38.78 mg/dL
Standard Deviation 163.30
|
4.56 mg/dL
Standard Deviation 73.52
|
-45.44 mg/dL
Standard Deviation 120.43
|
22.29 mg/dL
Standard Deviation 57.79
|
1.94 mg/dL
Standard Deviation 52.43
|
SECONDARY outcome
Timeframe: 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.
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
-22.11 mg/dL
Standard Deviation 13.60
|
-29.11 mg/dL
Standard Deviation 20.26
|
-12.11 mg/dL
Standard Deviation 24.49
|
1.86 mg/dL
Standard Deviation 45.05
|
-1.43 mg/dL
Standard Deviation 32.90
|
|
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
|
-12.44 mg/dL
Standard Deviation 24.70
|
-29.44 mg/dL
Standard Deviation 27.13
|
-33.56 mg/dL
Standard Deviation 40.73
|
-15.29 mg/dL
Standard Deviation 8.24
|
-5.50 mg/dL
Standard Deviation 29.57
|
|
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
|
-9.33 mg/dL
Standard Deviation 13.46
|
-14.22 mg/dL
Standard Deviation 16.93
|
-16.33 mg/dL
Standard Deviation 18.33
|
-11.56 mg/dL
Standard Deviation 31.13
|
-7.50 mg/dL
Standard Deviation 18.40
|
|
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
|
-25.11 mg/dL
Standard Deviation 19.47
|
-20.78 mg/dL
Standard Deviation 19.39
|
-11.33 mg/dL
Standard Deviation 21.17
|
0.00 mg/dL
Standard Deviation 42.90
|
-6.47 mg/dL
Standard Deviation 26.19
|
|
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
|
-14.67 mg/dL
Standard Deviation 14.40
|
-30.89 mg/dL
Standard Deviation 17.41
|
-15.11 mg/dL
Standard Deviation 20.76
|
-2.29 mg/dL
Standard Deviation 41.43
|
0.33 mg/dL
Standard Deviation 30.00
|
|
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
|
207.33 mg/dL
Standard Deviation 41.11
|
205.00 mg/dL
Standard Deviation 50.52
|
213.22 mg/dL
Standard Deviation 53.38
|
170.22 mg/dL
Standard Deviation 41.37
|
181.94 mg/dL
Standard Deviation 34.45
|
|
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
|
-29.11 mg/dL
Standard Deviation 14.42
|
-27.44 mg/dL
Standard Deviation 17.08
|
-24.22 mg/dL
Standard Deviation 25.73
|
1.29 mg/dL
Standard Deviation 41.63
|
-6.60 mg/dL
Standard Deviation 37.37
|
SECONDARY outcome
Timeframe: 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.
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
133.56 mg/dL
Standard Deviation 43.47
|
123.44 mg/dL
Standard Deviation 35.72
|
130.67 mg/dL
Standard Deviation 33.83
|
96.11 mg/dL
Standard Deviation 37.88
|
102.44 mg/dL
Standard Deviation 31.64
|
|
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
|
-20.44 mg/dL
Standard Deviation 22.32
|
-13.67 mg/dL
Standard Deviation 14.74
|
-2.33 mg/dL
Standard Deviation 22.11
|
-0.29 mg/dL
Standard Deviation 38.98
|
2.73 mg/dL
Standard Deviation 20.35
|
|
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
|
-11.44 mg/dL
Standard Deviation 16.84
|
-30.89 mg/dL
Standard Deviation 14.08
|
-7.89 mg/dL
Standard Deviation 17.92
|
-9.57 mg/dL
Standard Deviation 35.69
|
5.07 mg/dL
Standard Deviation 24.99
|
|
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
|
-22.44 mg/dL
Standard Deviation 16.49
|
-19.89 mg/dL
Standard Deviation 14.68
|
-11.56 mg/dL
Standard Deviation 17.92
|
-1.00 mg/dL
Standard Deviation 38.18
|
4.80 mg/dL
Standard Deviation 30.59
|
|
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
|
-5.89 mg/dL
Standard Deviation 19.37
|
-6.89 mg/dL
Standard Deviation 15.26
|
-6.67 mg/dL
Standard Deviation 19.46
|
-11.00 mg/dL
Standard Deviation 23.51
|
-3.63 mg/dL
Standard Deviation 14.80
|
|
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
|
-15.00 mg/dL
Standard Deviation 14.11
|
-20.22 mg/dL
Standard Deviation 16.75
|
-0.67 mg/dL
Standard Deviation 16.86
|
-3.86 mg/dL
Standard Deviation 38.21
|
5.79 mg/dL
Standard Deviation 27.50
|
|
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 24.40
|
-10.38 mg/dL
Standard Deviation 15.15
|
-27.11 mg/dL
Standard Deviation 22.05
|
-19.78 mg/dL
Standard Deviation 22.97
|
-17.43 mg/dL
Standard Deviation 16.70
|
-2.25 mg/dL
Standard Deviation 23.61
|
SECONDARY outcome
Timeframe: 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.
Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
-3.44 mg/dL
Standard Deviation 5.98
|
1.22 mg/dL
Standard Deviation 5.70
|
-4.44 mg/dL
Standard Deviation 3.21
|
1.14 mg/dL
Standard Deviation 4.49
|
-5.00 mg/dL
Standard Deviation 7.99
|
|
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
|
-5.78 mg/dL
Standard Deviation 10.59
|
0.00 mg/dL
Standard Deviation 5.15
|
-4.44 mg/dL
Standard Deviation 4.93
|
-0.86 mg/dL
Standard Deviation 4.38
|
-6.93 mg/dL
Standard Deviation 9.52
|
|
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 5.10
|
-5.78 mg/dL
Standard Deviation 7.61
|
-1.56 mg/dL
Standard Deviation 5.70
|
-4.22 mg/dL
Standard Deviation 4.12
|
1.00 mg/dL
Standard Deviation 3.79
|
-3.36 mg/dL
Standard Deviation 9.04
|
|
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
|
-5.22 mg/dL
Standard Deviation 6.50
|
-3.22 mg/dL
Standard Deviation 7.24
|
-4.44 mg/dL
Standard Deviation 6.98
|
-2.29 mg/dL
Standard Deviation 4.07
|
-3.50 mg/dL
Standard Deviation 6.86
|
|
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
|
43.33 mg/dL
Standard Deviation 9.51
|
46.44 mg/dL
Standard Deviation 11.51
|
43.89 mg/dL
Standard Deviation 13.66
|
49.44 mg/dL
Standard Deviation 14.05
|
48.94 mg/dL
Standard Deviation 9.33
|
|
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
|
-4.33 mg/dL
Standard Deviation 7.73
|
1.00 mg/dL
Standard Deviation 4.66
|
-3.11 mg/dL
Standard Deviation 3.69
|
-2.43 mg/dL
Standard Deviation 2.64
|
-6.20 mg/dL
Standard Deviation 7.80
|
|
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 4.10
|
-3.67 mg/dL
Standard Deviation 6.36
|
1.33 mg/dL
Standard Deviation 6.75
|
-4.56 mg/dL
Standard Deviation 4.07
|
-0.67 mg/dL
Standard Deviation 7.07
|
-3.88 mg/dL
Standard Deviation 8.02
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 6 and 14Population: 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.
Baseline value was collected at 0 hour on Day 1 for lactate.
Outcome measures
| Measure |
PF-04937319 10 mg
n=9 Participants
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 Participants
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 Participants
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 Participants
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 Participants
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 Participants
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
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
|
10.17 mg/dL
Standard Deviation 3.07
|
14.14 mg/dL
Standard Deviation 7.82
|
21.66 mg/dL
Standard Deviation 9.45
|
11.57 mg/dL
Standard Deviation 4.30
|
14.74 mg/dL
Standard Deviation 8.58
|
|
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
|
1.02 mg/dL
Standard Deviation 1.77
|
-2.08 mg/dL
Standard Deviation 7.14
|
-6.08 mg/dL
Standard Deviation 10.72
|
2.61 mg/dL
Standard Deviation 6.60
|
-1.45 mg/dL
Standard Deviation 9.27
|
|
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
|
-0.09 mg/dL
Standard Deviation 2.02
|
-3.88 mg/dL
Standard Deviation 6.63
|
-6.97 mg/dL
Standard Deviation 10.42
|
2.60 mg/dL
Standard Deviation 2.98
|
-2.59 mg/dL
Standard Deviation 8.67
|
Adverse Events
PF-04937319 10 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-04937319 30 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04937319 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-04937319 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-04937319 300 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-04937319 10 mg
n=9 participants at risk
Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
|
PF-04937319 30 mg
n=9 participants at risk
Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 50 mg
n=9 participants at risk
Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
|
PF-04937319 100 mg
n=9 participants at risk
Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
|
PF-04937319 300 mg
n=9 participants at risk
Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
|
Placebo
n=16 participants at risk
Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/16
|
|
Gastrointestinal disorders
Dyspepsia
|
22.2%
2/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Infections and infestations
Infected sebaceous cyst
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
3/9
|
33.3%
3/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/16
|
|
Investigations
Blood glucose decreased
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9
|
66.7%
6/9
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9
|
6.2%
1/16
|
|
Nervous system disorders
Headache
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
22.2%
2/9
|
0.00%
0/16
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/9
|
6.2%
1/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER