Trial Outcomes & Findings for STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT (NCT NCT04616027)
NCT ID: NCT04616027
Last Updated: 2024-05-10
Results Overview
Cmax was the maximum observed plasma concentration and was directly observed from data.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3
Results posted on
2024-05-10
Participant Flow
Participants were allocated to treatment at 3 sites in 1 country. 42 participants were allocated to treatment, 3 did not receive treatment. A total of 39 participants were treated and completed the study.
Participant milestones
| Measure |
Healthy and Normal Renal Function
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
7
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT
Baseline characteristics by cohort
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.1 Years
STANDARD_DEVIATION 2.30 • n=5 Participants
|
64.1 Years
STANDARD_DEVIATION 7.17 • n=7 Participants
|
68.0 Years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
67.0 Years
STANDARD_DEVIATION 9.09 • n=4 Participants
|
59.8 Years
STANDARD_DEVIATION 4.98 • n=21 Participants
|
63.2 Years
STANDARD_DEVIATION 8.31 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Cmax was the maximum observed plasma concentration and was directly observed from data.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Plasma PF-06882961
|
38.80 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
38.67 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
39.19 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
56.68 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
39.18 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
PRIMARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-06882961
|
362.4 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
404.8 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
487.0 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
|
543.2 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 48
|
408.8 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
PRIMARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-06882961
|
359.9 ng*hr/mL
Geometric Coefficient of Variation 30
|
399.6 ng*hr/mL
Geometric Coefficient of Variation 50
|
466.3 ng*hr/mL
Geometric Coefficient of Variation 19
|
538.2 ng*hr/mL
Geometric Coefficient of Variation 44
|
404.8 ng*hr/mL
Geometric Coefficient of Variation 46
|
PRIMARY outcome
Timeframe: 0 (pre dose), 4 hours (post dose) on Day 1Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Fu was defined as fraction of unbound drug in plasma.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Fraction Unbound (fu) of Plasma PF-06882961
|
0.01519 Ratio
Geometric Coefficient of Variation 9
|
0.01542 Ratio
Geometric Coefficient of Variation 15
|
0.01699 Ratio
Geometric Coefficient of Variation 14
|
0.01861 Ratio
Geometric Coefficient of Variation 18
|
0.01960 Ratio
Geometric Coefficient of Variation 18
|
SECONDARY outcome
Timeframe: 0 (pre dose), 4 hours (post dose) on Day 1Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Cmax,u was defined as maximum observed concentration of unbound drug.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration of Unbound Drug (Cmax,u) of Plasma PF-06882961
|
0.5896 ng/mL
Geometric Coefficient of Variation 34
|
0.5963 ng/mL
Geometric Coefficient of Variation 60
|
0.6662 ng/mL
Geometric Coefficient of Variation 32
|
1.055 ng/mL
Geometric Coefficient of Variation 25
|
0.7680 ng/mL
Geometric Coefficient of Variation 57
|
SECONDARY outcome
Timeframe: 0 (pre dose), 4 hours (post dose) on Day 1Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
AUCinf,u was defined as unbound area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Unbound Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf,u) of Plasma PF-06882961
|
5.505 ng*hr/mL
Geometric Coefficient of Variation 37
|
6.246 ng*hr/mL
Geometric Coefficient of Variation 45
|
7.931 ng*hr/mL
Geometric Coefficient of Variation 16
|
10.01 ng*hr/mL
Geometric Coefficient of Variation 31
|
8.019 ng*hr/mL
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: 0 (pre dose), 4 hours (post dose) on Day 1Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
AUClast,u was defined as unbound area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Unbound Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast,u) of Plasma PF-06882961
|
5.470 ng*hr/mL
Geometric Coefficient of Variation 38
|
6.162 ng*hr/mL
Geometric Coefficient of Variation 46
|
7.922 ng*hr/mL
Geometric Coefficient of Variation 14
|
10.01 ng*hr/mL
Geometric Coefficient of Variation 30
|
7.927 ng*hr/mL
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Plasma PF-06882961
|
55.17 liter per hour (L/hr)
Geometric Coefficient of Variation 30
|
49.32 liter per hour (L/hr)
Geometric Coefficient of Variation 49
|
41.08 liter per hour (L/hr)
Geometric Coefficient of Variation 19
|
36.83 liter per hour (L/hr)
Geometric Coefficient of Variation 48
|
48.93 liter per hour (L/hr)
Geometric Coefficient of Variation 46
|
SECONDARY outcome
Timeframe: 0 (pre dose), 4 hours (post dose) on Day 1Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
CLu/F was defined as apparent clearance of unbound drug.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Clearance of Unbound Drug After Oral Administration (CLu/F) of Plasma PF-06882961
|
3631 L/hr
Geometric Coefficient of Variation 37
|
3200 L/hr
Geometric Coefficient of Variation 45
|
2525 L/hr
Geometric Coefficient of Variation 16
|
2000 L/hr
Geometric Coefficient of Variation 31
|
2494 L/hr
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Vz/F was defined as apparent volume of distribution.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Plasma PF-06882961
|
600.8 liter (L)
Geometric Coefficient of Variation 59
|
552.3 liter (L)
Geometric Coefficient of Variation 89
|
372.5 liter (L)
Geometric Coefficient of Variation 38
|
438.4 liter (L)
Geometric Coefficient of Variation 85
|
565.9 liter (L)
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: 0 (pre dose), 4 hours (post dose) on Day 1Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Vz,u/F was defined as apparent volume of distribution of unbound drug.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Unbound Vz/F (Vz,u/F) of Plasma PF-06882961
|
39530 Liter
Geometric Coefficient of Variation 68
|
35810 Liter
Geometric Coefficient of Variation 84
|
22890 Liter
Geometric Coefficient of Variation 30
|
23800 Liter
Geometric Coefficient of Variation 63
|
28900 Liter
Geometric Coefficient of Variation 51
|
SECONDARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Tmax was defined as time to maximum observed concentration. Observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Time of Observed Maximum Plasma Concentration (Tmax) of Plasma PF-06882961
|
5.00 hour (hr)
Interval 3.0 to 8.0
|
5.00 hour (hr)
Interval 5.0 to 8.13
|
6.00 hour (hr)
Interval 3.0 to 12.0
|
5.50 hour (hr)
Interval 4.0 to 6.0
|
5.00 hour (hr)
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3Population: All participants who received at least 1 dose of PF-06882961 and had at least 1 of the plasma PK parameters of interest calculated. Here, overall number of participants analyzed signifies number of participants evaluable for this outcome measure.
Plasma terminal elimination half-life (T1/2) is the time measured for the plasma concentration to decrease by one half at the terminal phase.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=6 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=7 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (T1/2) of Plasma PF-06882961
|
8.111 hr
Standard Deviation 3.4828
|
8.139 hr
Standard Deviation 2.5640
|
6.640 hr
Standard Deviation 2.6551
|
8.907 hr
Standard Deviation 4.0497
|
8.058 hr
Standard Deviation 0.84962
|
SECONDARY outcome
Timeframe: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants with adverse events
|
1 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants with serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants with severe adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants discontinued from study due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants discontinued study drug due to AE and continue Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants with dose reduced or temporary discontinuation due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
Laboratory test abnormalities included hematology, chemistry and urinalysis.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hematology: Erythrocytes (10^6/mm^3) < 0.8x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) < 0.9x LLN
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hematology: Lymphocytes (10^3/mm^3) < 0.8x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Hematology: Eosinophils (10^3/mm^3) > 1.2x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Bilirubin (mg/dL) > 1.5x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Blood Urea Nitrogen (mg/dL) > 1.3x ULN
|
0 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Creatinine (mg/dL) > 1.3x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Urate (mg/dL) > 1.2x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Magnesium (mg/dL) < 0.9x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Phosphate (mg/dL) > 1.2x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Bicarbonate (mEq/L) < 0.9x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Glucose (mg/dL) > 1.5x ULN
|
0 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Clinical Chemistry: Triacylglycerol Lipase (U/L) > 1.5x ULN
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urinalysis: URINE Glucose (Scalar) ≥ 1
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urinalysis: URINE Protein (Scalar) ≥ 1
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urinalysis: Leukocyte Esterase ≥ 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urinalysis: Hyaline Casts (/LPF) > 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urinalysis: Bacteria (/HPF) > 20
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
The vital signs were measured included pulse rate (beats/min) and blood pressure (mmHg).
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Value < 90mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Value < 50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg increase
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
PULSE RATE (BPM): Value < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
PULSE RATE (BPM): Value > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
ECG parameters included QTCF, PR interval, and QRS interval.
Outcome measures
| Measure |
Healthy and Normal Renal Function
n=8 Participants
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 Participants
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 Participants
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF NOT OTHERWISE SPECIFIED (MSEC): Value > 500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF NOT OTHERWISE SPECIFIED (MSEC): 30 < Chg ≤ 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF NOT OTHERWISE SPECIFIED (MSEC): Chg > 60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Healthy and Normal Renal Function
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
T2DM Normal Renal Function
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
T2DM Mild Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
T2DM Moderate Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
T2DM Severe Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy and Normal Renal Function
n=8 participants at risk
Healthy participants whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Normal Renal Function
n=7 participants at risk
Participants with type 2 diabetes mellitus (T2DM) whose estimated glomerular filtration rate (eGFR) ≥90mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Mild Renal Impairment
n=8 participants at risk
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 60-89mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Moderate Renal Impairment
n=8 participants at risk
Participants with T2DM whose estimated glomerular filtration rate (eGFR) 30-59mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
T2DM Severe Renal Impairment
n=8 participants at risk
Participants with T2DM whose estimated glomerular filtration rate (eGFR) \<30mL/min were included in this group. PF-06882961 was administered at a dose of 20 mg on Day 1.
|
Total
n=39 participants at risk
Treatment Group Description TBD
|
|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.1%
2/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
10.3%
4/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Fatigue
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
28.6%
2/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
5.1%
2/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
1/7 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.6%
1/39 • From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
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