Trial Outcomes & Findings for A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008) (NCT NCT06295796)
NCT ID: NCT06295796
Last Updated: 2026-02-17
Results Overview
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.
COMPLETED
PHASE1
18 participants
Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
2026-02-17
Participant Flow
Participant milestones
| Measure |
Moderate Renal Impairment
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
Healthy
Healthy participants received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
Baseline characteristics by cohort
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 5.25 • n=25 Participants
|
63.7 Years
STANDARD_DEVIATION 6.44 • n=20 Participants
|
67.8 Years
STANDARD_DEVIATION 5.88 • n=45 Participants
|
63.8 Years
STANDARD_DEVIATION 6.43 • n=76 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
8 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=25 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
10 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
1 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=25 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
17 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=25 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=45 Participants
|
12 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=25 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
6 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=76 Participants
|
|
Baseline estimated glomerular filtration rate (eGFR)
|
100.758 mL/min
STANDARD_DEVIATION 9.9802 • n=25 Participants
|
44.292 mL/min
STANDARD_DEVIATION 8.8361 • n=20 Participants
|
22.875 mL/min
STANDARD_DEVIATION 5.0729 • n=45 Participants
|
55.975 mL/min
STANDARD_DEVIATION 34.6775 • n=76 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma
|
769 nM·hr
Geometric Coefficient of Variation 21.4
|
1160 nM·hr
Geometric Coefficient of Variation 24.6
|
1430 nM·hr
Geometric Coefficient of Variation 20.1
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma
|
918 nM·hr
Geometric Coefficient of Variation 22.2
|
1640 nM·hr
Geometric Coefficient of Variation 30.0
|
2060 nM·hr
Geometric Coefficient of Variation 24.0
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of MK-8527 in Plasma
|
112 nM
Geometric Coefficient of Variation 25.7
|
161 nM
Geometric Coefficient of Variation 48.9
|
91.7 nM
Geometric Coefficient of Variation 22.1
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-8527 in Plasma
|
0.75 hr
Interval 0.52 to 1.53
|
0.75 hr
Interval 0.5 to 1.0
|
0.99 hr
Interval 0.25 to 6.0
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma
|
84.2 hr
Geometric Coefficient of Variation 14.1
|
118 hr
Geometric Coefficient of Variation 32.5
|
113 hr
Geometric Coefficient of Variation 38.0
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf).
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Apparent Clearance (CL/F) of MK-8527 in Plasma
|
21.2 Liter/hr
Geometric Coefficient of Variation 22.2
|
11.8 Liter/hr
Geometric Coefficient of Variation 30.0
|
9.45 Liter/hr
Geometric Coefficient of Variation 24.0
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz).
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma
|
2570 Liter
Geometric Coefficient of Variation 29.7
|
2020 Liter
Geometric Coefficient of Variation 27.0
|
1540 Liter
Geometric Coefficient of Variation 36.5
|
SECONDARY outcome
Timeframe: Up to approximately 29 daysPopulation: All participants who received the study drug
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 29 daysPopulation: All participants who received the study drug
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Number of Participants Who Discontinue Study Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs)
|
217 pmol*hr/10^6 cells
Geometric Coefficient of Variation 37.2
|
493 pmol*hr/10^6 cells
Geometric Coefficient of Variation 51.6
|
588 pmol*hr/10^6 cells
Geometric Coefficient of Variation 37.6
|
SECONDARY outcome
Timeframe: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. The λz could not be determined for 1 participant with Moderate RI and 2 participants with Severe RI, therefore AUC0-inf could not be calculated.
Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=4 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
AUC0-inf of MK-8527-TP in PBMCs
|
235 pmol*hr/10^6 cells
Geometric Coefficient of Variation 35.9
|
468 pmol*hr/10^6 cells
Geometric Coefficient of Variation 27.5
|
552 pmol*hr/10^6 cells
Geometric Coefficient of Variation 5.9
|
SECONDARY outcome
Timeframe: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure.
Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Cmax was defined as the maximum observed concentration of MK-8527-TP after the administration of a given dose.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Cmax of MK-8527-TP in PBMCs
|
1.77 pmol/10^6 cells
Geometric Coefficient of Variation 28.4
|
3.82 pmol/10^6 cells
Geometric Coefficient of Variation 78.4
|
3.18 pmol/10^6 cells
Geometric Coefficient of Variation 14.7
|
SECONDARY outcome
Timeframe: 168 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure.
Blood samples were collected at pre-specified time points to determine the C168 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C168 of MK-8527-TP in PBMCs was determined.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs
|
0.470 pmol/10^6 cells
Geometric Coefficient of Variation 39.3
|
0.948 pmol/10^6 cells
Geometric Coefficient of Variation 118.9
|
1.03 pmol/10^6 cells
Geometric Coefficient of Variation 46.0
|
SECONDARY outcome
Timeframe: 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. 1 healthy control participant out of 6 had C672 concentration as below the limit of quantitation (BLQ). Therefore, geometric mean and geometric coefficient of variation were not determined for healthy participants.
Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C672 of MK-8527-TP in PBMCs was determined.
Outcome measures
| Measure |
Healthy
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment
|
—
|
0.183 pmol/10^6 cells
Geometric Coefficient of Variation 54.1
|
0.248 pmol/10^6 cells
Geometric Coefficient of Variation 50.7
|
SECONDARY outcome
Timeframe: 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure. 1 healthy control participant out of 6 had C672 concentration as below the limit of quantitation (BLQ). THe BLQ value was set as '0' and the median and range is reported for healthy participants.
Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Since ≤ 50% of healthy participants had BLQ values, the BLQ value was set to zero and the median, minimum, and maximum was reported for C672.
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
C672 of MK-8527-TP in PBMCs in Healthy Participants
|
0.0673 pmol/10^6 cells
Interval 0.0 to 0.0874
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure.
Blood samples were collected at pre-specified time points to determine the Tmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Tmax of MK-8527-TP was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=6 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=6 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
Tmax of MK-8527-TP in PBMCs
|
23.08 hr
Interval 11.92 to 23.92
|
23.92 hr
Interval 23.53 to 167.07
|
23.01 hr
Interval 23.0 to 23.53
|
SECONDARY outcome
Timeframe: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model, and had available data for the outcome measure.
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).
Outcome measures
| Measure |
Healthy
n=6 Participants
Healthy participants received a single dose of MK-8527 on Day 1.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of MK-8527 on Day 1.
|
Severe Renal Impairment
n=4 Participants
Participants with severe renal impairment received a single dose of MK-8527 on Day 1.
|
|---|---|---|---|
|
T1/2 of MK-8527-TP in PBMCs
|
170 hr
Geometric Coefficient of Variation 44.1
|
212 hr
Geometric Coefficient of Variation 24.6
|
251 hr
Geometric Coefficient of Variation 36.2
|
Adverse Events
Moderate Renal Impairment
Severe Renal Impairment
Healthy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee All unpublished information given to Celerion and/or the CRU by the Sponsor shall not be published or disclosed to a third party without the prior written consent of the Sponsor. The data generated by this study are considered confidential information and the property of the Sponsor. This confidential information may be published only in collaboration with participating personnel from the Sponsor or upon Sponsor's written consent to publish the article.
- Publication restrictions are in place
Restriction type: OTHER