Trial Outcomes & Findings for Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009) (NCT NCT01948986)
NCT ID: NCT01948986
Last Updated: 2019-02-18
Results Overview
Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose
Results posted on
2019-02-18
Participant Flow
Participant milestones
| Measure |
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
8
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
Baseline characteristics by cohort
| Measure |
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 Years
FULL_RANGE 3.5 • n=5 Participants
|
66.4 Years
FULL_RANGE 2.4 • n=7 Participants
|
65.8 Years
FULL_RANGE 7.9 • n=5 Participants
|
61.2 Years
FULL_RANGE 10.3 • n=4 Participants
|
64.3 Years
FULL_RANGE 3.9 • n=21 Participants
|
64.4 Years
n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Baseline Urinary Glucose Excretion (UGE)
|
8.2 Grams
FULL_RANGE 10.49 • n=5 Participants
|
0.1 Grams
FULL_RANGE 10.21 • n=7 Participants
|
0.2 Grams
FULL_RANGE 0.93 • n=5 Participants
|
2.3 Grams
FULL_RANGE 3.44 • n=4 Participants
|
0.1 Grams
FULL_RANGE 0.04 • n=21 Participants
|
1.8 Grams
n=10 Participants
|
|
Baseline eGFR
|
92.1 mL/min/1.73 m²
FULL_RANGE 14.10 • n=5 Participants
|
64.7 mL/min/1.73 m²
FULL_RANGE 7.52 • n=7 Participants
|
37.1 mL/min/1.73 m²
FULL_RANGE 6.92 • n=5 Participants
|
17.0 mL/min/1.73 m²
FULL_RANGE 7.51 • n=4 Participants
|
88.5 mL/min/1.73 m²
FULL_RANGE 11.64 • n=21 Participants
|
60.5 mL/min/1.73 m²
n=10 Participants
|
|
Baseline Inhibition of Glucose Readsorption
|
2.7 Percentage
FULL_RANGE 3.45 • n=5 Participants
|
0.1 Percentage
FULL_RANGE 5.17 • n=7 Participants
|
0.3 Percentage
FULL_RANGE 1.05 • n=5 Participants
|
3.3 Percentage
FULL_RANGE 19.42 • n=4 Participants
|
0.0 Percentage
FULL_RANGE 0.02 • n=21 Participants
|
1.1 Percentage
n=10 Participants
|
|
Baseline Fluid Balance
|
-644.0 Milliliters
FULL_RANGE 668.11 • n=5 Participants
|
-274.8 Milliliters
FULL_RANGE 570.44 • n=7 Participants
|
238.8 Milliliters
FULL_RANGE 763.10 • n=5 Participants
|
-267.5 Milliliters
FULL_RANGE 430.85 • n=4 Participants
|
-359.5 Milliliters
FULL_RANGE 693.65 • n=21 Participants
|
-243.1 Milliliters
n=10 Participants
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.
Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 Extrapolated to Infinite Time (AUCinf)
|
1908 ng•hr/mL
Geometric Coefficient of Variation 28
|
2075 ng•hr/mL
Geometric Coefficient of Variation 19
|
1895 ng•hr/mL
Geometric Coefficient of Variation 23
|
1236 ng•hr/mL
Geometric Coefficient of Variation 27
|
1199 ng•hr/mL
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast.
Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)
|
1814 ng•hr/mL
Geometric Coefficient of Variation 27
|
2011 ng•hr/mL
Geometric Coefficient of Variation 18
|
1816 ng•hr/mL
Geometric Coefficient of Variation 23
|
1214 ng•hr/mL
Geometric Coefficient of Variation 27
|
1174 ng•hr/mL
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for CL/F.
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) for Plasma Ertugliflozin
|
130.9 mL/min
Geometric Coefficient of Variation 28
|
120.4 mL/min
Geometric Coefficient of Variation 19
|
132.0 mL/min
Geometric Coefficient of Variation 23
|
202.1 mL/min
Geometric Coefficient of Variation 27
|
208.8 mL/min
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Ertugliflozin
|
313.1 ng/mL
Geometric Coefficient of Variation 30
|
305.7 ng/mL
Geometric Coefficient of Variation 23
|
196.4 ng/mL
Geometric Coefficient of Variation 28
|
219.3 ng/mL
Geometric Coefficient of Variation 26
|
215.9 ng/mL
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Time for Cmax (Tmax) for Plasma Ertugliflozin
|
1.50 Hours
Interval 1.0 to 2.0
|
1.50 Hours
Interval 0.5 to 2.0
|
1.51 Hours
Interval 0.5 to 3.02
|
1.00 Hours
Interval 1.0 to 2.0
|
1.00 Hours
Interval 1.0 to 1.5
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) for Plasma Ertugliflozin
|
25.94 Hours
Standard Deviation 13.98
|
22.89 Hours
Standard Deviation 7.35
|
24.17 Hours
Standard Deviation 5.98
|
17.71 Hours
Standard Deviation 3.53
|
14.62 Hours
Standard Deviation 6.37
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Vz/F.
VzF is the apparent volume of distribution during terminal phase after oral / extravascular administration. VzF = Dose/(AUCinf × kel) where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution Following Oral Administration (Vz/F) for Plasma Ertugliflozin
|
254.5 Liters
Geometric Coefficient of Variation 50
|
228.3 Liters
Geometric Coefficient of Variation 27
|
268.8 Liters
Geometric Coefficient of Variation 41
|
304.5 Liters
Geometric Coefficient of Variation 39
|
239.7 Liters
Geometric Coefficient of Variation 53
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Fu.
Fraction of unbound (not protein-bound) drug in plasma. Fu is determined using in vitro equilibrium dialysis method: concentration in buffer at equilibrium/concentration in plasma at equilibrium. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Unbound Fraction (Fu) for Plasma Ertugliflozin
|
0.03458 Percent of Unbound Drug
Standard Deviation 0.0027696
|
0.03804 Percent of Unbound Drug
Standard Deviation 0.0021287
|
0.04107 Percent of Unbound Drug
Standard Deviation 0.0036621
|
0.03484 Percent of Unbound Drug
Standard Deviation 0.0014822
|
0.03437 Percent of Unbound Drug
Standard Deviation 0.0011219
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96 = Sum of \[urine concentration × sample volume\] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96)
|
0.1081 Milligrams
Geometric Coefficient of Variation 54
|
0.09682 Milligrams
Geometric Coefficient of Variation 21
|
0.05843 Milligrams
Geometric Coefficient of Variation 40
|
0.1231 Milligrams
Geometric Coefficient of Variation 48
|
0.1494 Milligrams
Geometric Coefficient of Variation 55
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96% = Ae96 / Dose × 100 Ae96 = Sum of \[urine concentration × sample volume\] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Percent of Dose Recovered Unchanged in Urine From 0 to 96 Hours Postdose (for Ertugliflozin Only) (Ae96%)
|
0.7200 Percent
Geometric Coefficient of Variation 54
|
0.6456 Percent
Geometric Coefficient of Variation 21
|
0.3893 Percent
Geometric Coefficient of Variation 40
|
0.8213 Percent
Geometric Coefficient of Variation 48
|
0.9952 Percent
Geometric Coefficient of Variation 55
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for CLr.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Renal Clearance (CLr) for Urinary Ertugliflozin
|
0.9872 mL/min
Geometric Coefficient of Variation 45
|
0.8024 mL/min
Geometric Coefficient of Variation 34
|
0.5360 mL/min
Geometric Coefficient of Variation 23
|
1.682 mL/min
Geometric Coefficient of Variation 33
|
2.092 mL/min
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Up to 19 daysPopulation: The analysis population was defined as all treated participants.
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 5 daysPopulation: The analysis population was defined as all treated participants.
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.
Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06481944 From Time 0 Extrapolated to Infinite Time (AUCinf)
|
2620 ng•hr/mL
Geometric Coefficient of Variation 34
|
3668 ng•hr/mL
Geometric Coefficient of Variation 56
|
2742 ng•hr/mL
Geometric Coefficient of Variation 41
|
1113 ng•hr/mL
Geometric Coefficient of Variation 32
|
1559 ng•hr/mL
Geometric Coefficient of Variation 21
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast.
Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06481944 From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)
|
2517 ng•hr/mL
Geometric Coefficient of Variation 32
|
3552 ng•hr/mL
Geometric Coefficient of Variation 55
|
2642 ng•hr/mL
Geometric Coefficient of Variation 40
|
1090 ng•hr/mL
Geometric Coefficient of Variation 33
|
1536 ng•hr/mL
Geometric Coefficient of Variation 21
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Glucuronide Metabolite PF-06481944
|
309.0 ng/mL
Geometric Coefficient of Variation 30
|
358.5 ng/mL
Geometric Coefficient of Variation 28
|
218.6 ng/mL
Geometric Coefficient of Variation 33
|
168.6 ng/mL
Geometric Coefficient of Variation 34
|
217.8 ng/mL
Geometric Coefficient of Variation 18
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Time for Cmax (Tmax) for Plasma Glucuronide Metabolite PF-06481944
|
2.00 Hours
Interval 1.5 to 4.0
|
3.00 Hours
Interval 1.5 to 3.0
|
3.00 Hours
Interval 1.5 to 4.0
|
2.00 Hours
Interval 1.5 to 3.0
|
2.00 Hours
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) for Plasma Glucuronide Metabolite PF-06481944
|
22.04 Hours
Standard Deviation 12.15
|
23.33 Hours
Standard Deviation 6.15
|
22.83 Hours
Standard Deviation 5.92
|
17.51 Hours
Standard Deviation 5.69
|
16.68 Hours
Standard Deviation 9.46
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96 = Sum of \[urine concentration × sample volume\] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) for Glucuronide Metabolite PF-06481944
|
5.861 Milligrams
Geometric Coefficient of Variation 36
|
3.768 Milligrams
Geometric Coefficient of Variation 40
|
1.630 Milligrams
Geometric Coefficient of Variation 41
|
6.225 Milligrams
Geometric Coefficient of Variation 32
|
7.056 Milligrams
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for CLr.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
CLr for Urinary Glucuronide Metabolite PF-06481944
|
38.73 mL/min.
Geometric Coefficient of Variation 58
|
17.67 mL/min.
Geometric Coefficient of Variation 56
|
10.27 mL/min.
Geometric Coefficient of Variation 80
|
94.53 mL/min.
Geometric Coefficient of Variation 25
|
76.28 mL/min.
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.
Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06685948 From Time 0 Extrapolated to Infinite Time (AUCinf)
|
604.1 ng•hr/mL
Geometric Coefficient of Variation 39
|
950.9 ng•hr/mL
Geometric Coefficient of Variation 75
|
975.0 ng•hr/mL
Geometric Coefficient of Variation 53
|
337.6 ng•hr/mL
Geometric Coefficient of Variation 27
|
383.9 ng•hr/mL
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast.
Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06685948 From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)
|
579.8 ng•hr/mL
Geometric Coefficient of Variation 37
|
917.7 ng•hr/mL
Geometric Coefficient of Variation 74
|
922.1 ng•hr/mL
Geometric Coefficient of Variation 51
|
329.1 ng•hr/mL
Geometric Coefficient of Variation 28
|
371.9 ng•hr/mL
Geometric Coefficient of Variation 27
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Glucuronide Metabolite PF-06685948
|
53.56 ng/mL
Geometric Coefficient of Variation 17
|
63.10 ng/mL
Geometric Coefficient of Variation 42
|
46.42 ng/mL
Geometric Coefficient of Variation 35
|
43.90 ng/mL
Geometric Coefficient of Variation 24
|
44.44 ng/mL
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Time for Cmax (Tmax) for Plasma Glucuronide Metabolite PF-06685948
|
3.00 Hours
Interval 2.0 to 4.03
|
4.00 Hours
Interval 2.0 to 4.0
|
3.51 Hours
Interval 3.0 to 4.02
|
2.00 Hours
Interval 2.0 to 3.0
|
2.00 Hours
Interval 1.5 to 3.0
|
PRIMARY outcome
Timeframe: Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dosePopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) for Plasma Glucuronide Metabolite PF-06685948
|
21.71 Hours
Standard Deviation 11.26
|
22.49 Hours
Standard Deviation 5.30
|
25.22 Hours
Standard Deviation 10.42
|
15.68 Hours
Standard Deviation 4.66
|
14.87 Hours
Standard Deviation 7.77
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Ae96 = Sum of \[urine concentration × sample volume\] for each collection interval from 0 to 96 hours post dose. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) for Glucuronide Metabolite PF-06685948
|
0.7882 Milligrams
Geometric Coefficient of Variation 33
|
0.6603 Milligrams
Geometric Coefficient of Variation 49
|
0.3195 Milligrams
Geometric Coefficient of Variation 43
|
0.8287 Milligrams
Geometric Coefficient of Variation 40
|
0.9575 Milligrams
Geometric Coefficient of Variation 45
|
PRIMARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for CLr.
Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Renal Clearance (CLr) for Urinary Glucuronide Metabolite PF-06685948
|
22.50 mL/min
Geometric Coefficient of Variation 45
|
11.95 mL/min
Geometric Coefficient of Variation 49
|
5.778 mL/min
Geometric Coefficient of Variation 43
|
41.42 mL/min
Geometric Coefficient of Variation 31
|
41.82 mL/min
Geometric Coefficient of Variation 24
|
PRIMARY outcome
Timeframe: Baseline and 24 HoursPopulation: The analysis population was defined as all treated participants who had at least one concentration measurement for plasma glucose concentration.
Inhibition of Glucose Reabsorption = 100 \* urinary glucose excretion / (eGFR(ML/MIN) \* Weighted Mean Plasma Glucose \* 0.0144). 0.0144 is a unit conversion factor used to make the ratio unitless. Geometric Coefficient of Variation was reported as a percent.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Change From Baseline in 24 Hour Inhibition of Glucose Reabsorption
|
25.58 Percentage
Geometric Coefficient of Variation 77
|
28.84 Percentage
Geometric Coefficient of Variation 34
|
24.25 Percentage
Geometric Coefficient of Variation 61
|
29.19 Percentage
Geometric Coefficient of Variation 34
|
33.34 Percentage
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: For 24 hours before Baseline (-48 to -24 hours) and up to 24 hours after dosing on Day 1 (Up to 24 hours)Population: The analysis population was defined as all treated participants who had at least one measurement for fluid balance.
Fluid balance = fluid intake - urine output.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Change From Baseline in 24 Hour Fluid Balance
|
-937.00 Milliliters
Standard Deviation 539.14 • Interval -1345.2 to -528.79
|
-696.38 Milliliters
Standard Deviation 832.57 • Interval -1104.58 to -288.17
|
111.50 Milliliters
Standard Deviation 736.79 • Interval -359.85 to 582.85
|
-478.63 Milliliters
Standard Deviation 583.02
|
-660.67 Milliliters
Standard Deviation 515.48 • Interval -1132.02 to -189.31
|
SECONDARY outcome
Timeframe: 0-4, 4-8, 8-12, 12-24 hours after dosing on Day 1Population: The analysis population was defined as all treated participants who had at least one concentration measurement for UGE0-24hr.
Participants were asked to void at the end of each prescribed interval with forced voids prior to start and at the end of each interval.
Outcome measures
| Measure |
Ertugliflozin 15 mg (T2DM With Mild Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
Ertugliflozin 15 mg (T2DM With Moderate Renal Impairment)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
Ertugliflozin 15 mg (T2DM and With Severe Renal Impairment)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Ertugliflozin 15 mg (Healthy Part. With Normal Renal Function)
n=8 Participants
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
Ertugliflozin 15 mg (T2DM With Normal Renal Function)
n=6 Participants
Ertugliflozin (15 mg), oral, administered in participants with Type 2 Diabetes Mellitus (T2DM) and with normal renal function
|
|---|---|---|---|---|---|
|
Urinary Glucose Excretion Over 24 Hours (UGE0-24hr) for Ertugliflozin
|
35.98 Grams
Geometric Coefficient of Variation 113
|
27.55 Grams
Geometric Coefficient of Variation 68
|
10.09 Grams
Geometric Coefficient of Variation 57
|
46.33 Grams
Geometric Coefficient of Variation 31
|
72.31 Grams
Geometric Coefficient of Variation 30
|
Adverse Events
T2DM Normal Renal Function
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
T2DM Mild Renal Impairment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
T2DM Moderate Renal Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
T2DM Severe Renal Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Healthy Normal Renal Function
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
T2DM Normal Renal Function
n=6 participants at risk
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function
|
T2DM Mild Renal Impairment
n=8 participants at risk
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment
|
T2DM Moderate Renal Impairment
n=8 participants at risk
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment
|
T2DM Severe Renal Impairment
n=6 participants at risk
Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment
|
Healthy Normal Renal Function
n=8 participants at risk
Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
General disorders
Catheter site erythema
|
16.7%
1/6 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
33.3%
2/6 • Number of events 2 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
16.7%
1/6 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/8 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
0.00%
0/6 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
12.5%
1/8 • Number of events 1 • Up to 19 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator will provide manuscripts, abstracts, or the full text of any other intended disclosure (poster presentation, invited speaker or guest lecturer presentation, etc.) to the sponsor at least 30 days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, investigator agrees to delay the disclosure for a period not to exceed an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER