Trial Outcomes & Findings for Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005) (NCT NCT03259087)
NCT ID: NCT03259087
Last Updated: 2019-04-19
Results Overview
Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS).
COMPLETED
PHASE1
42 participants
Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants
2019-04-19
Participant Flow
Participant milestones
| Measure |
Part 1: Mild Renal Impairment (RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 2: End-stage Renal Disease Undergoing Hemodialysis
End-stage renal disease (ESRD) participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after hemodialysis (HD) in Period 1 and just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
|
|---|---|---|---|---|---|
|
Part 1 and Period 1 of Part 2
STARTED
|
8
|
8
|
8
|
10
|
8
|
|
Part 1 and Period 1 of Part 2
COMPLETED
|
8
|
8
|
8
|
10
|
7
|
|
Part 1 and Period 1 of Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Period 2 of Part 2
STARTED
|
0
|
0
|
0
|
0
|
7
|
|
Period 2 of Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
|
Period 2 of Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1: Mild Renal Impairment (RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 2: End-stage Renal Disease Undergoing Hemodialysis
End-stage renal disease (ESRD) participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after hemodialysis (HD) in Period 1 and just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
|
|---|---|---|---|---|---|
|
Part 1 and Period 1 of Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Period 2 of Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
Baseline characteristics by cohort
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants
n=10 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 2: End-stage Renal Disease Undergoing Hemodialysis
n=8 Participants
End-stage renal disease (ESRD) participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after hemodialysis (HD) in Period 1 and just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.3 Years
STANDARD_DEVIATION 5.65 • n=5 Participants
|
67.0 Years
STANDARD_DEVIATION 9.24 • n=7 Participants
|
57.3 Years
STANDARD_DEVIATION 13.83 • n=5 Participants
|
61.2 Years
STANDARD_DEVIATION 8.36 • n=4 Participants
|
51.9 Years
STANDARD_DEVIATION 8.68 • n=21 Participants
|
61.1 Years
STANDARD_DEVIATION 10.83 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Body Mass Index
|
28.125 kg/m^2
n=5 Participants
|
27.625 kg/m^2
n=7 Participants
|
28.625 kg/m^2
n=5 Participants
|
28.800 kg/m^2
n=4 Participants
|
29.875 kg/m^2
n=21 Participants
|
28.619 kg/m^2
n=8 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS).
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to Infinity (AUC0-inf)
|
104 µM*hr
Interval 87.2 to 125.0
|
141 µM*hr
Interval 115.0 to 174.0
|
83.5 µM*hr
Interval 75.0 to 92.9
|
244 µM*hr
Interval 169.0 to 352.0
|
81.8 µM*hr
Interval 72.4 to 92.4
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to the Time of the Last Quantifiable Sample (AUC0-last)
|
103 µM*hr
Interval 86.7 to 123.0
|
139 µM*hr
Interval 114.0 to 170.0
|
83.0 µM*hr
Interval 74.5 to 92.5
|
237 µM*hr
Interval 166.0 to 338.0
|
81.4 µM*hr
Interval 72.0 to 92.0
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to 24 Hours After Dosing (AUC0-24)
|
96.2 µM*hr
Interval 82.0 to 113.0
|
127 µM*hr
Interval 107.0 to 152.0
|
79.7 µM*hr
Interval 71.6 to 88.7
|
182 µM*hr
Interval 136.0 to 243.0
|
78.1 µM*hr
Interval 69.2 to 88.3
|
—
|
PRIMARY outcome
Timeframe: At the end of the infusion (0.5 hours after infusion start) on Day 1Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Plasma Concentration of MK-3866 at the End of the Infusion (Ceoi)
|
26.6 µM
Interval 22.3 to 31.8
|
27.7 µM
Interval 24.2 to 31.7
|
27.0 µM
Interval 23.9 to 30.5
|
29.7 µM
Interval 25.4 to 34.7
|
26.9 µM
Interval 23.7 to 30.5
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the combined comparator experimental groups.
Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=10 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration of MK-3866 (Cmax)
|
27.4 µM
Interval 26.0 to 28.9
|
28.0 µM
Interval 26.4 to 29.7
|
28.7 µM
Interval 26.4 to 31.2
|
26.7 µM
Interval 24.8 to 28.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Plasma Clearance of MK-3866 (CL)
|
3.80 L/hr
Interval 3.17 to 4.55
|
2.80 L/hr
Interval 2.28 to 3.44
|
4.75 L/hr
Interval 4.27 to 5.28
|
1.62 L/hr
Interval 1.12 to 2.35
|
4.85 L/hr
Interval 4.29 to 5.48
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Plasma Concentration of MK-3866 (Tmax)
|
0.50 Hours
Interval 0.47 to 0.5
|
0.49 Hours
Interval 0.47 to 0.5
|
0.50 Hours
Interval 0.47 to 0.5
|
0.50 Hours
Interval 0.47 to 0.53
|
0.50 Hours
Interval 0.47 to 0.5
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric % coefficient of variation (%CV).
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Elimination Terminal Half-life of Plasma MK-3866 (t1/2)
|
7.38 Hours
Geometric Coefficient of Variation 13.3
|
8.23 Hours
Geometric Coefficient of Variation 17.0
|
7.00 Hours
Geometric Coefficient of Variation 12.7
|
14.7 Hours
Geometric Coefficient of Variation 17.8
|
6.90 Hours
Geometric Coefficient of Variation 13.0
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participantsPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Volume of Distribution of Plasma MK-3866 (Vz)
|
40.4 Liters
Geometric Coefficient of Variation 18.3
|
33.3 Liters
Geometric Coefficient of Variation 18.0
|
48.0 Liters
Geometric Coefficient of Variation 17.3
|
34.4 Liters
Geometric Coefficient of Variation 29.5
|
48.3 Liters
Geometric Coefficient of Variation 17.7
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC0-inf of Plasma MK-3866
|
323 µM*hr
Interval 260.0 to 401.0
|
129 µM*hr
Interval 103.0 to 161.0
|
81.3 µM*hr
Interval 70.6 to 93.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC0-last of Plasma MK-3866
|
294 µM*hr
Interval 241.0 to 358.0
|
118 µM*hr
Interval 97.4 to 144.0
|
80.9 µM*hr
Interval 70.2 to 93.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC0-24 of Plasma MK-3866
|
203 µM*hr
Interval 174.0 to 238.0
|
84.7 µM*hr
Interval 74.6 to 96.1
|
77.8 µM*hr
Interval 67.5 to 89.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At the end of the infusion (0.5 hours after infusion start) on Day 1 of Period 1 and Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Ceoi of Plasma MK-3866
|
26.3 µM
Interval 22.7 to 30.3
|
25.3 µM
Interval 19.1 to 33.4
|
26.8 µM
Interval 23.1 to 31.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Cmax of Plasma MK-3866
|
26.6 µM
Interval 23.1 to 30.6
|
25.3 µM
Interval 19.1 to 33.4
|
26.8 µM
Interval 23.1 to 31.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: CL of Plasma MK-3866
|
1.23 L/hr
Interval 0.989 to 1.53
|
3.08 L/hr
Interval 2.47 to 3.85
|
4.87 L/hr
Interval 4.23 to 5.61
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Tmax of Plasma MK-3866
|
0.50 Hours
Interval 0.5 to 0.75
|
0.50 Hours
Interval 0.5 to 0.5
|
0.48 Hours
Interval 0.47 to 0.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: t1/2 of Plasma MK-3866
|
20.9 Hours
Geometric Coefficient of Variation 21.6
|
20.0 Hours
Geometric Coefficient of Variation 18.0
|
6.81 Hours
Geometric Coefficient of Variation 13.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=7 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Vz of Plasma MK-3866
|
37.1 Liters
Geometric Coefficient of Variation 20.0
|
89.1 Liters
Geometric Coefficient of Variation 12.2
|
47.9 Liters
Geometric Coefficient of Variation 18.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Total Amount of MK-3866 Excreted in the Urine Over 24 Hours (Ae0-24)
|
97.1 mg
Interval 79.6 to 118.0
|
69.2 mg
Interval 48.4 to 98.8
|
107 mg
Interval 89.0 to 130.0
|
34.6 mg
Interval 22.7 to 52.6
|
115 mg
Interval 96.4 to 137.0
|
—
|
SECONDARY outcome
Timeframe: Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t'-t")/AUC(t'-t"), where t'-t" is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Renal Clearance (CLr) of MK-3866
|
2.00 L/hr
Interval 1.5 to 2.66
|
1.08 L/hr
Interval 0.801 to 1.45
|
2.67 L/hr
Interval 2.18 to 3.27
|
0.377 L/hr
Interval 0.2 to 0.71
|
2.92 L/hr
Interval 2.33 to 3.65
|
—
|
SECONDARY outcome
Timeframe: Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1Population: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=9 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 1: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24)
|
0.485 Fraction of MK-3866 Excreted
Interval 0.398 to 0.592
|
0.346 Fraction of MK-3866 Excreted
Interval 0.242 to 0.494
|
0.537 Fraction of MK-3866 Excreted
Interval 0.445 to 0.648
|
0.173 Fraction of MK-3866 Excreted
Interval 0.114 to 0.263
|
0.575 Fraction of MK-3866 Excreted
Interval 0.482 to 0.686
|
—
|
SECONDARY outcome
Timeframe: Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=2 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=2 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Total Amount of MK-3866 Excreted Unchanged in the Urine Over the Period of 24 Hours (Ae0-24)
|
4.31 mg
Geometric Coefficient of Variation 42.6
|
2.21 mg
Geometric Coefficient of Variation 4.4
|
115 mg
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t'-t")/AUC(t'-t"), where t'-t" is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=2 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=2 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Renal Clearance (CLr) of MK-3866
|
0.0474 L/hr
Geometric Coefficient of Variation 8.5
|
0.0558 L/hr
Geometric Coefficient of Variation 15.8
|
2.92 L/hr
Geometric Coefficient of Variation 32.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=2 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=2 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24)
|
0.0216 Fraction of MK-3866 Excreted
Geometric Coefficient of Variation 42.6
|
0.0111 Fraction of MK-3866 Excreted
Geometric Coefficient of Variation 4.4
|
0.574 Fraction of MK-3866 Excreted
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma samples entering the dialyzer line were collected at pre-specified time points and Ca was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
0.75 hours after dosing
|
17.6 µM
Geometric Coefficient of Variation 15.6
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
1 hour after dosing
|
12.0 µM
Geometric Coefficient of Variation 35.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
1.5 hours after dosing
|
8.67 µM
Geometric Coefficient of Variation 33.1
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
2 hours after dosing
|
7.25 µM
Geometric Coefficient of Variation 10.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
2.5 hours after dosing
|
5.75 µM
Geometric Coefficient of Variation 8.5
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
3 hours after dosing
|
4.32 µM
Geometric Coefficient of Variation 35.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
3.5 hours after dosing
|
3.98 µM
Geometric Coefficient of Variation 10.3
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
4 hours after dosing
|
2.98 µM
Geometric Coefficient of Variation 31.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)
4.5 hours after dosing
|
2.57 µM
Geometric Coefficient of Variation 31.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma samples exiting the dialyzer line were collected at pre-specified time points and Cv was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
0.75 hours after dosing
|
8.32 µM
Geometric Coefficient of Variation 20.7
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
1 hour after dosing
|
7.16 µM
Geometric Coefficient of Variation 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
1.5 hours after dosing
|
5.17 µM
Geometric Coefficient of Variation 25.1
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
2 hours after dosing
|
3.71 µM
Geometric Coefficient of Variation 10.5
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
2.5 hours after dosing
|
2.92 µM
Geometric Coefficient of Variation 11.4
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
3 hours after dosing
|
2.69 µM
Geometric Coefficient of Variation 21.0
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
3.5 hours after dosing
|
2.12 µM
Geometric Coefficient of Variation 25.2
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
4 hours after dosing
|
2.10 µM
Geometric Coefficient of Variation 33.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)
4.5 hours after dosing
|
1.66 µM
Geometric Coefficient of Variation 49.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma samples entering the dialyzer line were collected at pre-specified time points and AUCD was assessed. AUCD values were determined from the Ca versus time profile during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line During the Dialysis Period (AUCD)
|
29.4 µM*hr
Geometric Coefficient of Variation 14.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC\[0.75-4.5\]Ca was assessed. AUC\[0.75-4.5\]Ca values were determined from the Ca versus time profile from 0.75 to 4.5 hours during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Ca)
|
23.9 µM*hr
Geometric Coefficient of Variation 19.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC\[0.75-4.5\]Cv was assessed. AUC\[0.75-4.5\]Cv values were determined from the Cv versus time profile from 0.75 to 4.5 hours during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Cv)
|
13.6 µM*hr
Geometric Coefficient of Variation 12.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma dialysis samples were collected at pre-specified time points and CLD was assessed. CLD was calculated as Q x R x (AUC\[1-4.5\]Ca - AUC\[1-4.5\]Cv) / AUC\[1-4.5\]Ca, where Q is the flow rate of blood through the dialyzer, and R is the ratio of blood drug concentration to plasma drug concentration. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Dialysis Clearance of MK-3866 Based on Plasma (CLD,Plasma)
|
4.81 L/hr
Geometric Coefficient of Variation 201.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma dialysis samples were collected at pre-specified time points and CD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
4 hours after dosing
|
0.695 µM
Standard Deviation 0.114
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
0.5 hours after dosing
|
1.07 µM
Standard Deviation 1.84
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
1 hour after dosing
|
3.02 µM
Standard Deviation 0.748
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
1.5 hours after dosing
|
2.29 µM
Standard Deviation 0.153
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
2 hours after dosing
|
1.62 µM
Standard Deviation 0.142
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
2.5 hours after dosing
|
1.30 µM
Standard Deviation 0.134
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
3 hours after dosing
|
1.08 µM
Standard Deviation 0.106
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
3.5 hours after dosing
|
0.894 µM
Standard Deviation 0.0896
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Concentration of MK-3866 in Dialysate Samples (CD)
4.5 hours after dosing
|
0.542 µM
Standard Deviation 0.251
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma dialysis samples were collected at pre-specified time points and AD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
0.5 hours after dosing
|
0.946 mg
Geometric Coefficient of Variation 8.6
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
1 hour after dosing
|
0.736 mg
Geometric Coefficient of Variation 31.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
1.5 hours after dosing
|
0.576 mg
Geometric Coefficient of Variation 6.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
2 hours after dosing
|
0.408 mg
Geometric Coefficient of Variation 8.7
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
2.5 hours after dosing
|
0.327 mg
Geometric Coefficient of Variation 10.7
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
3 hours after dosing
|
0.272 mg
Geometric Coefficient of Variation 10.3
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
3.5 hours after dosing
|
0.224 mg
Geometric Coefficient of Variation 10.3
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
4 hours after dosing
|
0.173 mg
Geometric Coefficient of Variation 17.2
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)
4.5 hours after dosing
|
0.158 mg
Geometric Coefficient of Variation 13.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma dialysis samples were collected at pre-specified time points and rr was assessed. rr was calculated as CD x dialysate flow rate. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
4.5 hours after dosing
|
9.51 mg/hr
Geometric Coefficient of Variation 13.7
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
0.5 hours after dosing
|
56.7 mg/hr
Geometric Coefficient of Variation 8.6
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
1 hour after dosing
|
44.2 mg/hr
Geometric Coefficient of Variation 31.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
1.5 hours after dosing
|
34.6 mg/hr
Geometric Coefficient of Variation 6.8
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
2 hours after dosing
|
24.5 mg/hr
Geometric Coefficient of Variation 8.7
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
2.5 hours after dosing
|
19.6 mg/hr
Geometric Coefficient of Variation 10.7
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
3 hours after dosing
|
16.3 mg/hr
Geometric Coefficient of Variation 10.3
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
3.5 hours after dosing
|
13.5 mg/hr
Geometric Coefficient of Variation 10.3
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)
4 hours after dosing
|
10.4 mg/hr
Geometric Coefficient of Variation 17.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma dialysis samples were collected at pre-specified time points and AD,total was assessed. AD,total was obtained by integrating the rr versus time profile over the dialysis session duration, using actual times relative to the start time of dialysis. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Cumulative Amount of MK-3866 Recovered From the Dialysate (AD,Total)
|
89.0 mg
Geometric Coefficient of Variation 9.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2Population: All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).
Plasma dialysis samples were collected at pre-specified time points and CLD,dialysate was assessed. CLD,dialysate was calculated as AD.total / AUCD. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Part 2: Hemodialysis Clearance of MK-3866 Based on the Dialysate(CLD,Dialysate)
|
6.01 L/hr
Geometric Coefficient of Variation 13.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosingPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
n=10 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Adverse Event (AE)
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosingPopulation: All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Outcome measures
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Mild + Moderate RI)
n=8 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the combined mild and moderate RI groups
|
Part 1: Severe Renal Impairment
n=8 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Healthy Participants (Severe RI)
n=7 Participants
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the severe RI group.
|
Part 1: Healthy Participants
n=10 Participants
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Number of Participants Discontinuing the Study Due to an Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Part 1: Mild Renal Impairment (RI)
Part 1: Moderate Renal Impairment
Part 1: Severe Renal Impairment
Part 2, Period 1: ESRD Undergoing HD (Dosed After HD)
Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)
Part 1: Healthy Participants
Serious adverse events
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 participants at risk
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Severe Renal Impairment
n=8 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 2, Period 1: ESRD Undergoing HD (Dosed After HD)
n=8 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2.
|
Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)
n=7 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
|
Part 1: Healthy Participants
n=10 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender, and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
12.5%
1/8 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
14.3%
1/7 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
Other adverse events
| Measure |
Part 1: Mild Renal Impairment (RI)
n=8 participants at risk
Participants received a single intravenous (IV) infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Moderate Renal Impairment
n=8 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 1: Severe Renal Impairment
n=8 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1.
|
Part 2, Period 1: ESRD Undergoing HD (Dosed After HD)
n=8 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just after HD in Period 1. There was a washout of at least 6 days before dosing in Period 2.
|
Part 2, Period 2: ESRD Undergoing HD (Dosed Before HD)
n=7 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1 just before HD in Period 2. There was a washout of at least 6 days before dosing in Period 2.
|
Part 1: Healthy Participants
n=10 participants at risk
Participants received a single IV infusion of MK-3886 200 mg over 30 minutes on Day 1. These healthy participants matched the gender, and mean age and BMI of the comparator groups.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
12.5%
1/8 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
10.0%
1/10 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
25.0%
2/8 • Number of events 2 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
12.5%
1/8 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
12.5%
1/8 • Number of events 1 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/8 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/7 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
0.00%
0/10 • Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing
All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will provide separate guidance on the criteria for publication of clinical trial data when contacted for permission to publish.
- Publication restrictions are in place
Restriction type: OTHER