Trial Outcomes & Findings for Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function (NCT NCT00717067)
NCT ID: NCT00717067
Last Updated: 2010-11-19
Results Overview
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms \* hour divided by milliliters (ng\*hr/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.
Results posted on
2010-11-19
Participant Flow
Two centers took part in this study between 15 July 2008 and 21 November 2008.
Subjects were enrolled into treatment groups (healthy subjects, mild, moderate, severe renal impairment, or end stage renal impairment on hemodialysis) based on creatinine clearance results obtained closest to the dosing date at screening as determined by the Cockcroft-Gault equation (with the exception of subjects undergoing hemodialysis).
Participant milestones
| Measure |
Healthy Subjects
(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Severe Renal Impairment
Maraviroc 300 mg single dose.
|
ESRD: Single Dose
(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|
|
Part 1a: Normal/Mild/Moderate Group
STARTED
|
6
|
6
|
6
|
0
|
0
|
|
Part 1a: Normal/Mild/Moderate Group
COMPLETED
|
6
|
6
|
5
|
0
|
0
|
|
Part 1a: Normal/Mild/Moderate Group
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
|
Part 1b: Severe Renal Impairment
STARTED
|
0
|
0
|
0
|
6
|
0
|
|
Part 1b: Severe Renal Impairment
COMPLETED
|
0
|
0
|
0
|
6
|
0
|
|
Part 1b: Severe Renal Impairment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: End Stage Renal Disease
STARTED
|
0
|
0
|
0
|
0
|
6
|
|
Part 2: End Stage Renal Disease
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
|
Part 2: End Stage Renal Disease
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy Subjects
(I) Maraviroc single 300 mg dose, followed 4 days later by (II) Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Severe Renal Impairment
Maraviroc 300 mg single dose.
|
ESRD: Single Dose
(I) Maraviroc single dose one hour following completion of morning hemodialysis, followed at least 1 week later by (II) Maraviroc single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|
|
Part 1a: Normal/Mild/Moderate Group
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Baseline characteristics by cohort
| Measure |
Healthy Subjects
n=6 Participants
Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min)
|
Mild Renal Impairment
n=6 Participants
Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min)
|
Moderate Renal Impairment
n=6 Participants
Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min)
|
Severe Renal Impairment
n=6 Participants
Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min)
|
ESRD on Hemodialysis
n=6 Participants
Subjects with End Stage Renal Disease Requiring Regular Hemodialysis 3 Times a Week for at Least 6 Weeks Prior to Screening (Creatinine Clearance \<30 mL/min)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18 - 44 years
|
0 years
n=5 Participants
|
0 years
n=7 Participants
|
1 years
n=5 Participants
|
1 years
n=4 Participants
|
1 years
n=21 Participants
|
3 years
n=8 Participants
|
|
Age, Customized
45 - 64 years
|
5 years
n=5 Participants
|
4 years
n=7 Participants
|
0 years
n=5 Participants
|
2 years
n=4 Participants
|
4 years
n=21 Participants
|
15 years
n=8 Participants
|
|
Age, Customized
>= 65 years
|
1 years
n=5 Participants
|
2 years
n=7 Participants
|
5 years
n=5 Participants
|
3 years
n=4 Participants
|
1 years
n=21 Participants
|
12 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms \* hour divided by milliliters (ng\*hr/mL).
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)
|
7356.3 ng*hr/mL
Standard Deviation 2313.45
|
9502.1 ng*hr/mL
Standard Deviation 3599.32
|
6496.0 ng*hr/mL
Standard Deviation 1795.89
|
1320.7 ng*hr/mL
Standard Deviation 988.66
|
4255.5 ng*hr/mL
Standard Deviation 2424.19
|
2636.5 ng*hr/mL
Standard Deviation 1123.34
|
2770.1 ng*hr/mL
Standard Deviation 1356.56
|
PRIMARY outcome
Timeframe: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.
AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms \* hours divided by milliliters (ng.hr/mL).
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
AUCtau
|
5341.4 ng*hr/mL
Standard Deviation 1498.27
|
8118.7 ng*hr/mL
Standard Deviation 2995.27
|
6193.3 ng*hr/mL
Standard Deviation 1762.41
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
950.91 ng/mL
Standard Deviation 220.368
|
1150.74 ng/mL
Standard Deviation 392.167
|
674.20 ng/mL
Standard Deviation 275.722
|
335.60 ng/mL
Standard Deviation 393.024
|
801.16 ng/mL
Standard Deviation 525.656
|
576.7 ng/mL
Standard Deviation 339.27
|
478.5 ng/mL
Standard Deviation 198.81
|
SECONDARY outcome
Timeframe: 2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Percent protein binding (protein unbound maraviroc (MVC) fraction \[percent free\]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Plasma Protein Binding
maximum protein unbound MVC fraction
|
26.6 percent free
|
29.1 percent free
|
31.6 percent free
|
28.2 percent free
|
28.1 percent free
|
27.8 percent free
|
—
|
|
Plasma Protein Binding
minimum protein unbound MVC fraction
|
19.7 percent free
Interval 14.6 to 28.2
|
15.3 percent free
Interval 15.3 to 29.1
|
18.1 percent free
Interval 18.1 to 31.6
|
14.6 percent free
Interval 19.2 to 28.1
|
19.2 percent free
Interval 18.2 to 27.8
|
18.2 percent free
Interval 18.2 to 27.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.
Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms \* hour divided by millilters (ng\*hr/mL).
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Time Curve From 0 to Infinity (AUCinf)
|
1348.4 ng*hr/mL
Standard Deviation 986.65
|
4367.7 ng*hr/mL
Standard Deviation 2518.78
|
2677.4 ng*hr/mL
Standard Deviation 1149.85
|
2805.5 ng*hr/mL
Standard Deviation 1374.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Time of First Occurrence (Tmax)
|
1.000 hours
Interval 0.5 to 2.0
|
1.500 hours
Interval 0.5 to 4.0
|
2.000 hours
Interval 0.5 to 4.02
|
2.500 hours
Interval 0.5 to 4.02
|
2.500 hours
Interval 0.5 to 4.0
|
3.000 hours
Interval 1.0 to 4.0
|
2.000 hours
Interval 0.5 to 4.17
|
SECONDARY outcome
Timeframe: Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Half-life (t1/2)
|
14.22 hour
Standard Deviation 1.166
|
16.84 hour
Standard Deviation 5.568
|
16.99 hour
Standard Deviation 3.141
|
14.36 hour
Standard Deviation 4.030
|
17.29 hour
Standard Deviation 4.171
|
15.03 hour
Standard Deviation 3.329
|
13.86 hour
Standard Deviation 1.051
|
SECONDARY outcome
Timeframe: Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Renal clearance (CLR) measured in milliliters per minute (mL/min).
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function
|
105.7 mL/min
Standard Deviation 56.00
|
77.2 mL/min
Standard Deviation 36.71
|
62.5 mL/min
Standard Deviation 12.57
|
110.0 mL/min
Standard Deviation 38.67
|
26.6 mL/min
Standard Deviation 18.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.Population: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae
|
41.6 mg
Standard Deviation 22.45
|
39.1 mg
Standard Deviation 11.23
|
24.9 mg
Standard Deviation 8.88
|
10.8 mg
Standard Deviation 7.41
|
8.4 mg
Standard Deviation 6.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Before dialysisPopulation: Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.
CLdD: dialysate clearance before dialysis; measured in milliliters per minute.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD
|
36.42 mL/min
Standard Deviation 12.710
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-upPopulation: Safety analysis set: all subjects who received study medication. BL: Baseline.
Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: \<90 mmHg; and supine diastolic blood pressure, range: \<50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure
BL Supine Systolic Blood Pressure (BP) <90 mmHg
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure
Maximum Increase from BL: Supine Systolic BP≥ 30
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure
Maximum Decrease from BL: Supine Systolic BP ≥ 30
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure
BL Supine Diastolic Blood Pressure (BP) <50 mmHg
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure
Maximum Increase from BL: Supine Diastolic BP≥ 20
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure
Maximun Decrease from BL: Supine Diastolic BP ≥20
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-upPopulation: Safety analysis set: all subjects who received study medication.
Number of subjects with pulse rate \< 40 beats per minute (BPM), number of subjects with pulse rate \> 120 BPM.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute
Supine Pulse Rate >120 BPM
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute
Supine Pulse Rate <40 BPM
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
0 bpm
|
SECONDARY outcome
Timeframe: Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-upPopulation: Safety analysis set: all subjects who received study medication.
Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to \<480 msec, 480 to \<500 msec, and \>500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to \< 60 msec, and change = ≥ 60 msec.
Outcome measures
| Measure |
Healthy Subjects: Multiple Dose
n=6 Participants
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 6 days, and a single dose of both agents on Day 7.
|
Mild Renal Impairment: Multiple Dose
n=6 Participants
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment: Multiple Dose
n=5 Participants
Maraviroc 150 mg every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
Severe Renal Impairment: Single Dose
n=6 Participants
Maraviroc 300 mg single dose.
|
ESRD: Single Dose; After Dialysis
n=6 Participants
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Single Dose; Before Dialysis
n=6 Participants
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTCF Interval: > 500 msec
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Max. QTC Interval Increase from BL: change ≥30 <60
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTC Interval: 450 to < 480 msec
|
1 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
2 subjects
|
1 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTC Interval: 480 to < 500 msec
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTC Interval: > 500 msec
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTCB Interval: 450 to < 480 msec
|
1 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTCB Interval: 480 to < 500 msec
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTCB Interval: > 500 msec
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTCF Interval: 450 to 480 msec
|
1 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
1 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
Maximum QTCF Interval: 480 to < 500 msec
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals
QTC Interval Increase from BL: change ≥ 60
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
0 subjects
|
Adverse Events
Healthy Subjects
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mild Renal Impairment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Moderate Renal Impairment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Healthy Subjects: Single Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Severe Renal Impairment:
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ESRD: Dosing After Dialysis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ESRD: Dosing Before Dialysis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Subjects
n=6 participants at risk
Maraviroc 150 mg twice a day (BID) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Mild Renal Impairment
n=6 participants at risk
Maraviroc 150 mg once a day (QD) co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Moderate Renal Impairment
n=6 participants at risk
Maraviroc 150 milligrams (mg) every 48 hours co-administered with saquinavir 1,000 mg/ritonavir 100 mg twice a day (BID) for 7 days.
|
Healthy Subjects: Single Dose
n=6 participants at risk
Maraviroc 300 mg single dose.
|
Severe Renal Impairment:
n=6 participants at risk
Maraviroc 300 mg single dose.
|
ESRD: Dosing After Dialysis
n=6 participants at risk
Maraviroc 300 mg single dose one hour following completion of morning hemodialysis.
|
ESRD: Dosing Before Dialysis
n=6 participants at risk
Maraviroc 300 mg single dose three hours prior to start of hemodialysis.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
conjunctival hyperaemia
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
visual impairment
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
abdominal pain upper
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
diarrhea
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
dry mouth
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
dyspepsia
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
flatulence
|
33.3%
2/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
nausea
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
General disorders
fatigue
|
0.00%
0/6
|
33.3%
2/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
pain
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
sensation of foreign body
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
rhinitis
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
wound
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
blood bilirubin increased
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
blood creatinine increased
|
0.00%
0/6
|
66.7%
4/6
|
66.7%
4/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
blood urea increased
|
0.00%
0/6
|
50.0%
3/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
renal function test abnormal
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hyperuricaemia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
dizziness
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
headache
|
33.3%
2/6
|
50.0%
3/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
nocturia
|
0.00%
0/6
|
50.0%
3/6
|
50.0%
3/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Renal and urinary disorders
renal pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
|
Vascular disorders
orthostatic hypotension
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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