Trial Outcomes & Findings for Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655) (NCT NCT01432535)
NCT ID: NCT01432535
Last Updated: 2017-04-07
Results Overview
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
From hour 0 (pre-dose) to 288 hours post-dose
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Participants With Moderate Renal Impairment
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Healthy Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
12
|
|
Overall Study
COMPLETED
|
7
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.33 Years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
64.00 Years
STANDARD_DEVIATION 6.23 • n=7 Participants
|
52.67 Years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
57.83 Years
STANDARD_DEVIATION 10.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
|
305315.22 pg*hr/mL
Interval 175840.19 to 530125.58
|
435500.38 pg*hr/mL
Interval 248562.28 to 763030.4
|
658413.69 pg*hr/mL
Interval 395164.74 to 10907032.58
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) up to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
AUC From Time 0 to the Last Measurable Sample (AUC0-last)
|
286946.43 pg*hr/mL
Interval 164687.09 to 499967.87
|
408889.84 pg*hr/mL
Interval 232550.52 to 718944.43
|
598863.88 pg*hr/mL
Interval 358269.15 to 1001029.37
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
2547.85 pg/mL
Interval 1115.61 to 5818.84
|
3210.16 pg/mL
Interval 1386.73 to 7431.24
|
3551.03 pg/mL
Interval 1653.85 to 7624.49
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) up to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Time to Maximum Observed Serum Concentration (Tmax)
|
12.0 hours
Interval 9.0 to 72.0
|
12.0 hours
Interval 12.0 to 72.0
|
60.0 hours
Interval 24.0 to 96.3
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) up to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Apparent Terminal Half-life (T1/2)
|
41.9 Hours
Geometric Coefficient of Variation 31.9 • Interval 9.0 to 72.0
|
50.7 Hours
Geometric Coefficient of Variation 12.7 • Interval 12.0 to 72.0
|
58.1 Hours
Geometric Coefficient of Variation 17.2 • Interval 24.0 to 96.3
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) up to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
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).
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/F)
|
18.5 mL/min
Interval 10.42 to 32.85
|
12.72 mL/min
Interval 7.1 to 22.81
|
8.02 mL/min
Interval 4.71 to 13.64
|
PRIMARY outcome
Timeframe: From hour 0 (pre-dose) up to 288 hours post-dosePopulation: All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
Outcome measures
| Measure |
Healthy Participants
n=12 Participants
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F)
|
90.63 Liters
Interval 41.76 to 196.69
|
72.26 Liters
Interval 32.88 to 158.82
|
55.90 Liters
Interval 27.3 to 114.49
|
Adverse Events
Healthy Participants
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Participants With Moderate Renal Impairment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Participants With Severe Renal Impairment
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthy Participants
n=12 participants at risk
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=7 participants at risk
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 participants at risk
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
Other adverse events
| Measure |
Healthy Participants
n=12 participants at risk
Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Moderate Renal Impairment
n=7 participants at risk
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
Participants With Severe Renal Impairment
n=6 participants at risk
Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
28.6%
2/7 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
50.0%
3/6 • Number of events 3
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • Number of events 3
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
28.6%
2/7 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Chills
|
75.0%
9/12 • Number of events 9
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
71.4%
5/7 • Number of events 5
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
50.0%
3/6 • Number of events 3
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Fatigue
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
28.6%
2/7 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Feeling hot
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Injection site reaction
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Malaise
|
33.3%
4/12 • Number of events 4
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Pain
|
16.7%
2/12 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Pyrexia
|
75.0%
9/12 • Number of events 9
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
85.7%
6/7 • Number of events 7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
66.7%
4/6 • Number of events 5
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Investigations
Lymph node palpable
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
42.9%
3/7 • Number of events 3
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
3/12 • Number of events 3
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
28.6%
2/7 • Number of events 2
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Nervous system disorders
Headache
|
66.7%
8/12 • Number of events 10
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
57.1%
4/7 • Number of events 4
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
50.0%
3/6 • Number of events 3
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Nervous system disorders
Hypogeusia
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
16.7%
1/6 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/7
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
|
General disorders
Thirst
|
0.00%
0/12
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
14.3%
1/7 • Number of events 1
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
0.00%
0/6
One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The Investigator further agrees to provide review copies of abstracts or manuscripts for publication that report any results of the trial to the Sponsor 45 days prior to submission for publication or presentation. The Sponsor shall have the right to review and comment.
- Publication restrictions are in place
Restriction type: OTHER