Trial Outcomes & Findings for Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001) (NCT NCT02341599)
NCT ID: NCT02341599
Last Updated: 2019-02-18
Results Overview
AUC0-last is the area under the plasma concentration-time curve from the time of dosing to the last post-dose measurable concentration. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.
COMPLETED
PHASE1
40 participants
Groups A to D & Group E: Period 2: Pre-dose and 0.5, 1 (end of infusion; EOI), 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose
2019-02-18
Participant Flow
Healthy participants, participants with varying degrees of renal impairment (RI), and participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) (renal status was based on estimated glomerular filtration rate \[eGFR\]) were recruited at 2 study sites in the United States.
Participant milestones
| Measure |
Group A: Healthy
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD \[doses given 48 hours apart\]).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
Baseline characteristics by cohort
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD
n=8 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD \[doses given 48 hours apart\]).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 Years
STANDARD_DEVIATION 2.43 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 11.16 • n=7 Participants
|
69.1 Years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
65.3 Years
STANDARD_DEVIATION 10.47 • n=4 Participants
|
55.1 Years
STANDARD_DEVIATION 7.55 • n=21 Participants
|
61.7 Years
STANDARD_DEVIATION 44.81 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Groups A to D & Group E: Period 2: Pre-dose and 0.5, 1 (end of infusion; EOI), 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.
AUC0-last is the area under the plasma concentration-time curve from the time of dosing to the last post-dose measurable concentration. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Last Measurable Concentration (AUC0-last) of MK-6183
|
87.6 ug*hr/mL
Standard Deviation 8.49
|
114.8 ug*hr/mL
Standard Deviation 23.20
|
97.5 ug*hr/mL
Standard Deviation 25.71
|
228.0 ug*hr/mL
Standard Deviation 63.24
|
77.4 ug*hr/mL
Standard Deviation 8.79
|
270.6 ug*hr/mL
Standard Deviation 76.70
|
PRIMARY outcome
Timeframe: Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.
AUC0-∞ is the extrapolated area under the plasma concentration-time curve from the time of dosing to infinity. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and least squares (LS) mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
AUC From Dosing to ∞ (AUC0-∞) of MK-6183
|
87.8 ug*hr/mL
Standard Deviation 8.43
|
115.1 ug*hr/mL
Standard Deviation 23.44
|
97.8 ug*hr/mL
Standard Deviation 25.70
|
228.6 ug*hr/mL
Standard Deviation 63.44
|
86.8 ug*hr/mL
Standard Deviation 7.63
|
296.3 ug*hr/mL
Standard Deviation 78.66
|
PRIMARY outcome
Timeframe: Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.
Cmax is the maximum observed post-dose drug concentration in plasma. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and LS mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax) of MK-6183
|
45.3 ug/mL
Standard Deviation 5.23
|
47.2 ug/mL
Standard Deviation 8.19
|
24.2 ug/mL
Standard Deviation 5.95
|
30.8 ug/mL
Standard Deviation 3.90
|
12.9 ug/mL
Standard Deviation 4.60
|
15.6 ug/mL
Standard Deviation 6.59
|
PRIMARY outcome
Timeframe: Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.
CL is a measure of the clearance of drug from plasma via metabolism and excretion. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance of MK-6183 From Plasma (CL)
|
11.5 L/hour
Standard Deviation 1.23
|
9.0 L/hour
Standard Deviation 1.65
|
5.5 L/hour
Standard Deviation 1.64
|
2.4 L/hour
Standard Deviation 0.96
|
2.9 L/hour
Standard Deviation 0.26
|
0.9 L/hour
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.
Vss is the apparent volume of distribution at steady state for MK-6183. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of MK-6183
|
21.4 Liters
Standard Deviation 2.64
|
22.8 Liters
Standard Deviation 4.43
|
23.9 Liters
Standard Deviation 6.03
|
19.4 Liters
Standard Deviation 2.55
|
52.1 Liters
Standard Deviation 16.57
|
25.3 Liters
Standard Deviation 8.33
|
PRIMARY outcome
Timeframe: Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.
t½ is the amount of time required for the plasma concentration of MK-6183 to reduce by 50%. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) \[data from Periods 1 and 2 were analyzed separately\]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
n=7 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Apparent Plasma Half-life (t½) of MK-6183
|
2.1 Hours
Standard Deviation 0.45
|
2.8 Hours
Standard Deviation 0.33
|
4.0 Hours
Standard Deviation 1.28
|
6.8 Hours
Standard Deviation 1.90
|
18.1 Hours
Standard Deviation 3.79
|
19.2 Hours
Standard Deviation 5.04
|
PRIMARY outcome
Timeframe: Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HDPopulation: All participants who received MK-6183 and had viable results are included. For Group E, only results from Period 1 are presented as Period 2 sampling occurred post-HD.
Ae is the cumulative amount of drug excreted unchanged in urine or dialysate. For Groups A, B, C, and D, Ae was assessed in urine. For Group E: Period 1, Ae was assessed in dialysate (participants in Group E had no detectable urine data) at hourly collection intervals during HD (HD commenced 3 hours after dosing).
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=5 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=8 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Cumulative Amount of MK-6183 Excreted in Urine or Dialysate (Ae)
|
840.5 mg
Standard Deviation 65.33
|
699.1 mg
Standard Deviation 234.69
|
360.0 mg
Standard Deviation 33.82
|
309.1 mg
Standard Deviation 51.30
|
122.9 mg
Standard Deviation 29.21
|
—
|
PRIMARY outcome
Timeframe: 0 to 24, 24 to 48, and 48 to 72 hours post-dosePopulation: All participants who received MK-6183 and had viable results are included. CLr data are not presented for Group E.
CLr is the clearance of drug from plasma via the kidneys. Only data from Groups A, B, C, and D is presented; participants in Group E (Period 1) had no detectable urine data. Data for Group E: Period 1 are presented below in the dialysate clearance measure.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=5 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Renal Clearance of MK-6183 (CLr)
|
9.6 Liters/hour
Standard Deviation 1.14
|
6.1 Liters/hour
Standard Deviation 2.13
|
4.0 Liters/hour
Standard Deviation 1.61
|
1.7 Liters/hour
Standard Deviation 1.07
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HDPopulation: All participants who received MK-6183 and had viable results are included. Only data for Group E: Period 1 is presented.
CLd is the amount of drug cleared from plasma via dialysis. Only data collected during HD (Group E: Period 1) is presented (HD commenced 3 hours after dosing).
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Dialysate Clearance of MK-6183 (CLd)
|
1.4 Liters/hour
Standard Deviation 0.42
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HDPopulation: All participants who received MK-6183 and had viable results are included.
Fe is the fraction (percentage) of the administered dose that was excreted unchanged in urine (Groups A to D) or dialysate (Group E: Period 1; HD commenced 3 hours after dosing).
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=5 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=8 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Fraction of the Administered Dose of MK-6183 Excreted Unchanged in Urine or Dialysate (Fe)
|
84.0 mg
Standard Deviation 6.53
|
69.9 mg
Standard Deviation 23.47
|
72.0 mg
Standard Deviation 6.76
|
61.8 mg
Standard Deviation 10.26
|
49.2 mg
Standard Deviation 11.68
|
—
|
SECONDARY outcome
Timeframe: Up to 12 daysPopulation: All treated participants are included.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=8 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 daysPopulation: All treated participants are included.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Group A: Healthy
n=8 Participants
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 Participants
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 Participants
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 Participants
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD Period 1
n=8 Participants
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1.
|
Group E: ESRD-HD Period 2
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD).
|
|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing From the Study Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Group A: Healthy
Group B: Mild RI
Group C: Moderate RI
Group D: Severe RI
Group E: ESRD-HD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: Healthy
n=8 participants at risk
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group B: Mild RI
n=8 participants at risk
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2) received MK-6183 1 g as a 1-hour IV infusion.
|
Group C: Moderate RI
n=8 participants at risk
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group D: Severe RI
n=8 participants at risk
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2 \[not receiving HD\]) received MK-6183 500 mg as a 1-hour IV infusion.
|
Group E: ESRD-HD
n=8 participants at risk
Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD \[doses given 48 hours apart\]).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
General disorders
Infusion site erythema
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
General disorders
Infusion site pain
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Infections and infestations
Paronychia
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
25.0%
2/8 • Number of events 2 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
0.00%
0/8 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
12.5%
1/8 • Number of events 1 • Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place