Trial Outcomes & Findings for Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants (NCT NCT03796182)
NCT ID: NCT03796182
Last Updated: 2020-02-05
Results Overview
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
COMPLETED
PHASE1
12 participants
For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose
2020-02-05
Participant Flow
A total of 12 healthy participants were enrolled in the study and 6 participants were assigned in each of the 2 treatment sequences, all receiving study treatment.
Participant milestones
| Measure |
Metformin Then Metformin + PF-04965842
Participants were administered a single oral dose of metformin 500 mg on Day 1 in Period 1 followed by a washout period of at least 4 days. Then in Period 2 participants were administered a single oral dose of metformin 500 mg on Day 1 along with oral doses of PF-04965842 200 mg once daily (QD) for 2 days on Days 1-2.
|
Metformin + PF-04965842 Then Metformin
Participants were administered a single oral dose of metformin 500 mg on Day 1 along with oral doses of PF-04965842 200 mg QD for 2 days on Days 1-2 in Period 1 followed by a washout period of at least 4 days. Then in Period 2 participants were administered a single oral dose of metformin 500 mg on Day 1.
|
|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
6
|
6
|
|
Washout Period
COMPLETED
|
6
|
6
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
This reporting group refers to the total 12 participants who were enrolled in the study.
|
|---|---|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dosePopulation: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
Outcome measures
| Measure |
Metformin + PF-04965842
n=11 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Renal Clearance (CLr) of Metformin
|
32.18 litre per hour (L/hr)
Geometric Coefficient of Variation 39
|
33.33 litre per hour (L/hr)
Geometric Coefficient of Variation 28
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
AUCinf is a measure of the serum concentration of the drug over time. It was used to characterize drug absorption.
Outcome measures
| Measure |
Metformin + PF-04965842
n=8 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=11 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Metformin
|
5050 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 16
|
5202 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Metformin
|
634.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
720.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Tmax of metformin administrated with or without PF-04965842.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Time for Cmax (Tmax) of Metformin
|
4.00 Hours (hrs)
Interval 2.0 to 4.0
|
4.00 Hours (hrs)
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
AUClast of metformin administrated with or without PF-04965842.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Area Under the Plasma Concentration Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Metformin
|
4849 ng*h/mL
Geometric Coefficient of Variation 18
|
5145 ng*h/mL
Geometric Coefficient of Variation 18
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
CL/F is a quantitative measure of the rate at which drug was removed from the blood.
Outcome measures
| Measure |
Metformin + PF-04965842
n=8 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=11 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Apparent Clearance (CL/F) of Metformin
|
98.97 L/hr
Geometric Coefficient of Variation 16
|
96.13 L/hr
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
Vz/F 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 |
Metformin + PF-04965842
n=8 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=11 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Metformin
|
1087 liter (L)
Geometric Coefficient of Variation 42
|
1211 liter (L)
Geometric Coefficient of Variation 37
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2Population: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
t1/2 is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Metformin + PF-04965842
n=8 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=11 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Terminal Half-life (t1/2) of Metformin
|
8.318 hrs
Standard Deviation 4.2508
|
9.261 hrs
Standard Deviation 3.5165
|
SECONDARY outcome
Timeframe: For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dosePopulation: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.
Outcome measures
| Measure |
Metformin + PF-04965842
n=11 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Cumulative Amount of Drug Recovered Unchanged in Urine From 0 to 48 Hours (Ae) of Metformin
|
168.0 milligram (mg)
Interval 70.7 to 210.0
|
170.5 milligram (mg)
Interval 114.0 to 248.0
|
SECONDARY outcome
Timeframe: For both Period 1 and Period 2 at intervals of 0-12 and 12-24 hours post metformin dosePopulation: This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.
Ae% is percent of dose recovered unchanged in urine from 0 to 24 hours post-dose of metformin.
Outcome measures
| Measure |
Metformin + PF-04965842
n=11 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Percent of Dose Recovered Unchanged in Urine From 0 to 24 Hours (Ae%) of Metformin
|
33.60 percentage of dose
Interval 14.1 to 42.0
|
34.05 percentage of dose
Interval 22.7 to 49.7
|
SECONDARY outcome
Timeframe: Screening (within 28 days prior to Day 1) to Day 7Population: This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio, large unstained cells/leukocytes and large unstained cells), clinical chemistry (bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, urobilinogen and glucose -FASTING), urinalysis (specific gravity, pH, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite and leukocytes). Clinical significance of laboratory parameters is determined at the investigator's discretion.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (within 28 days prior to Day 1) to Day 7Population: This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
Criteria for change in vital signs: pulse rate value less than (\<) 40 beats per minute (bpm) or value over than (\>) 120 bpm, systolic blood pressure (SBP) value \< 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value \< 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine DBP Value < 50 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine DBP Chg ≥ 20 mmHg increase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine DBP Chg ≥ 20 mmHg decrease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine pulse rate Value < 40 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine pulse rate Value > 120 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine SBP Value < 90 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine SBP Chg ≥ 30 mmHg increase
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria
Supine SBP Chg ≥ 30 mmHg decrease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 40 (35 days after the last dose of metformin)Population: This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
AEs (all causalities)
|
6 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
AEs (treatment-related)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
SAEs (all causalities)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)
SAEs (treatment-related)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 40 (35 days after the last dose of metformin)Population: This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.
AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Metformin + PF-04965842
n=12 Participants
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 Participants
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related)
AEs (all causalities)
|
50.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related)
AEs (treatment-related)
|
41.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related)
SAEs (all causalities)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related)
SAEs (treatment-related)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Metformin + PF-04965842
Metformin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin + PF-04965842
n=12 participants at risk
This reporting group refers to the participants who were randomized to the group of concomitantly single oral administration of metformin 500 mg QD on Day 1 and oral administration of PF-04965842 200 mg QD for 2 days on Days 1-2 in either of the periods.
|
Metformin
n=12 participants at risk
This reporting group refers to the participants who were randomized to the group of single oral administration of metformin 500 mg QD on Day 1 in either of the periods.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • Number of events 4 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
25.0%
3/12 • Number of events 3 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
General disorders
Fatigue
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Number of events 1 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
0.00%
0/12 • Day 1 up to Day 40 (35 days after the last dose of metformin)
|
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