Moderate Renal Impairment
Conditions
Brief summary
This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and \<60milliliter/minute/1.73meters\^2 (ml/min/1.73m\^2). There is no formal hypothesis.
Interventions
10 mg capsule administered orally
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Good health based upon medical history, physical examination, vital signs, laboratory safety tests, and electrocardiograms (ECG) performed before randomization * Body mass index (BMI) ≥18 kg/m\^2 and ≤40 kg/m\^2 * Male participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm, PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or use acceptable contraception per study protocol * Female participants must be of non-childbearing potential * Moderate RI participants: Baseline estimated glomerular filtration rate (eGFR) ≥30 and \<60 mL/min/1.73 m\^2 based on the Modification of Diet in Renal Disease (MDRD) equation * Moderate Renal Impairment (RI) participants: No clinically significant change in renal status at least 1 month prior to dosing and not currently receiving or has not previously been on hemodialysis * Healthy Matched Controls: eGFR ≥80 mL/min/1.73 m\^2 based on the MDRD equation
Exclusion criteria
* Healthy Matched Controls: history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator * History of cancer, with the exception of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study * History of significant multiple and/or severe allergies * Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV) * History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit * Moderate RI participants: Does not agree to follow the smoking restrictions as defined by the study * Healthy Matched Controls: History of smoking and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening * Received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention with the exception of Corona virus disease (COVID-19) vaccine administration. Study intervention must be given at least 72 hours following or at least 48 hours prior to any COVID-19 vaccination * Consumes greater than 3 servings of alcoholic beverages per day * Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day * Regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity. |
| Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616. | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration. |
| Maximum Plasma Concentration (Cmax) of MK-0616 | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached. |
| Time to Maximum Plasma Concentration (Tmax) of MK-0616 | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached. |
| Apparent Terminal Half-life (t1/2) of MK-0616 | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616. |
| Apparent Clearance (CL/F) of MK-0616 | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma. |
| Apparent Volume of Distribution (Vz/F) of MK-0616 | Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose | Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 14 days | An AE was 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. |
| Number of Participants Who Discontinued From the Study Due to an AE | Up to approximately 14 days | An AE was 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who discontinued from the study due to an AE were reported. |
| Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616 | Predose and at 0, 4, 8, 12 and 24 hours postdose | Urine samples were collected at pre-specified time points to determine the AE0-24 of MK-0616. Ae0-24 was defined as the amount of MK-0616 recovered in urine from time 0-24 hours. |
| Fraction of Dose Recovered in Urine (Fe) of MK-0616 | Predose and at 0, 4, 8, 12, 24, 36 and 48 hours postdose | Urine samples were collected at pre-specified time points to determine the Fe of MK-0616. Fe was defined as the fraction of dose of MK-0616 recovered in urine. |
| Renal Clearance (CLr) of MK-0616 | Predose and 4, 8, 12, 24, 36, and 48 hours postdose | Urine samples were collected at pre-specified time points to determine the CLr of MK-0616. was defined as the time it takes for the MK-0616 to be completely removed by the kidneys. |
| Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Baseline (Predose) and up to 336 hours post dose | Urine samples were collected at pre-specified time points (baseline and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 and 336 hours postdose) to evaluate the reduction in free PCSK9 from baseline to up to 336 hours postdose after administration of MK-0616. The percent change from baseline in free PCSK9 was reported. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Recruitment details
Of 24 participants screened for inclusion, 18 participants were allocated to receive MK-0616 single dose 10-mg. All participants received at least one dose of study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Panel A - Moderate Renal Impairment (RI) Participants with moderate RI received a single dose of MK-616 10mg orally on Day 1. | 10 |
| Panel B - Healthy Controls Healthy matched control participants received a single dose of MK-0616 10 mg orally on Day 1. | 8 |
| Total | 18 |
Baseline characteristics
| Characteristic | Panel B - Healthy Controls | Total | Panel A - Moderate Renal Impairment (RI) |
|---|---|---|---|
| Age, Continuous | 60.4 Years STANDARD_DEVIATION 5 | 63.8 Years STANDARD_DEVIATION 6.1 | 66.5 Years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 13 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 14 Participants | 10 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 8 |
| other Total, other adverse events | 3 / 10 | 2 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 |
Outcome results
Primary
Apparent Clearance (CL/F) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the CL/F of MK-0616. CL/F was the apparent total clearance of MK-0616 in plasma over time, assessed as the rate at which MK-0616 was removed from the plasma.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for CL/F.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Apparent Clearance (CL/F) of MK-0616 | 14.2 Liter/hour |
| Panel B - Healthy Controls | Apparent Clearance (CL/F) of MK-0616 | 17.5 Liter/hour |
90% CI: [0.41, 1.62]
Primary
Apparent Terminal Half-life (t1/2) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the t1/2 of MK-0616. t1/2 was defined as the time required to divide the MK-0616 plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-0616.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for t1/2.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Apparent Terminal Half-life (t1/2) of MK-0616 | 55.1 Hour | Geometric Coefficient of Variation 44.1 |
| Panel B - Healthy Controls | Apparent Terminal Half-life (t1/2) of MK-0616 | 48.8 Hour | Geometric Coefficient of Variation 32 |
Primary
Apparent Volume of Distribution (Vz/F) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the Vz/F of MK-0616. Vz/F was the apparent volume of distribution of MK-0616 between the plasma and the rest of the body, after dose, assessed as the total volume of MK-0616 that would need to be uniformly distributed to achieve the desired plasma drug concentration.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for Vz/F.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Apparent Volume of Distribution (Vz/F) of MK-0616 | 1130 Liter |
| Panel B - Healthy Controls | Apparent Volume of Distribution (Vz/F) of MK-0616 | 1230 Liter |
90% CI: [0.6, 1.42]
Primary
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-0616. AUC0-inf was defined as the area under the concentration-time curve of MK-0616 from time zero to infinity.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for AUC0-inf.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 | 453 hour*nmol/Liter |
| Panel B - Healthy Controls | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of MK-0616 | 369 hour*nmol/Liter |
90% CI: [0.62, 2.44]
Primary
Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616.
Blood samples were collected at pre-specified timepoints to determine the AUC0-last of MK-0616. AUC0-last was defined as the area under the concentration-time curve of MK-0616 from time zero to last measurable concentration.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for AUC0-last.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616. | 312 hour*nmol/Liter |
| Panel B - Healthy Controls | Area Under the Concentration- Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of MK-0616. | 192 hour*nmol/Liter |
90% CI: [0.55, 4.83]
Primary
Maximum Plasma Concentration (Cmax) of MK-0616
Blood samples were collected at pre-specified time points to determine the Cmax of MK-0616. Cmax was defined as the maximum concentration of MK-0616 reached.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for Cmax.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Maximum Plasma Concentration (Cmax) of MK-0616 | 5.80 nmol/Liter |
| Panel B - Healthy Controls | Maximum Plasma Concentration (Cmax) of MK-0616 | 4.00 nmol/Liter |
90% CI: [0.7, 2.99]
Primary
Time to Maximum Plasma Concentration (Tmax) of MK-0616
Blood samples were collected at pre-specified timepoints to determine the Tmax of MK-0616. Tmax was defined as time to the maximum concentration of MK-0616 reached.
Time frame: Predose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for Tmax.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Time to Maximum Plasma Concentration (Tmax) of MK-0616 | 2.00 Hour |
| Panel B - Healthy Controls | Time to Maximum Plasma Concentration (Tmax) of MK-0616 | 4.66 Hour |
Secondary
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616
Urine samples were collected at pre-specified time points to determine the AE0-24 of MK-0616. Ae0-24 was defined as the amount of MK-0616 recovered in urine from time 0-24 hours.
Time frame: Predose and at 0, 4, 8, 12 and 24 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for Ae0-24.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616 | 0.0116 Miligram |
| Panel B - Healthy Controls | Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-0616 | 0.0141 Miligram |
90% CI: [0.22, 3.1]
Secondary
Fraction of Dose Recovered in Urine (Fe) of MK-0616
Urine samples were collected at pre-specified time points to determine the Fe of MK-0616. Fe was defined as the fraction of dose of MK-0616 recovered in urine.
Time frame: Predose and at 0, 4, 8, 12, 24, 36 and 48 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for Fe.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Fraction of Dose Recovered in Urine (Fe) of MK-0616 | 0.116 Percent |
| Panel B - Healthy Controls | Fraction of Dose Recovered in Urine (Fe) of MK-0616 | 0.141 Percent |
90% CI: [0.22, 3.1]
Secondary
Number of Participants Who Discontinued From the Study Due to an AE
An AE was 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who discontinued from the study due to an AE were reported.
Time frame: Up to approximately 14 days
Population: All allocated participants who received a dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Number of Participants Who Discontinued From the Study Due to an AE | 0 Participants |
| Panel B - Healthy Controls | Number of Participants Who Discontinued From the Study Due to an AE | 0 Participants |
Secondary
Number of Participants Who Experienced an Adverse Event (AE)
An AE was 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.
Time frame: Up to approximately 14 days
Population: All allocated participants who received a dose of intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Number of Participants Who Experienced an Adverse Event (AE) | 3 Participants |
| Panel B - Healthy Controls | Number of Participants Who Experienced an Adverse Event (AE) | 2 Participants |
Secondary
Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9)
Urine samples were collected at pre-specified time points (baseline and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 and 336 hours postdose) to evaluate the reduction in free PCSK9 from baseline to up to 336 hours postdose after administration of MK-0616. The percent change from baseline in free PCSK9 was reported.
Time frame: Baseline (Predose) and up to 336 hours post dose
Population: All allocated participants who received a dose of study intervention, and had a baseline measure and at least one postbaseline measure of PCSK9.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 3 hours postdose | -89.7 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 12 hours postdose | -71.8 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 2 hours postdose | -90.8 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 24 hours postdose | -67.2 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 5 hours postdose | -89.6 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 36 hours postdose | -54.9 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 1.5 hours postdose | -90.9 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 48 hours postdose | -44.9 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 8 hours postdose | -84.9 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 336 hours postdose | 5.00 Percent Change |
| Panel A - Moderate Renal Impairment (RI) | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 1 hour postdose | -80.5 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 336 hours postdose | 7.50 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 1 hour postdose | -66.6 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 1.5 hours postdose | -88.6 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 2 hours postdose | -87.1 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 3 hours postdose | -86.0 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 5 hours postdose | -83.6 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 8 hours postdose | -78.5 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 12 hours postdose | -60.8 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 24 hours postdose | -27.9 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 36 hours postdose | 1.38 Percent Change |
| Panel B - Healthy Controls | Percent Change From Baseline in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) | Change from baseline to 48 hours postdose | 5.11 Percent Change |
Secondary
Renal Clearance (CLr) of MK-0616
Urine samples were collected at pre-specified time points to determine the CLr of MK-0616. was defined as the time it takes for the MK-0616 to be completely removed by the kidneys.
Time frame: Predose and 4, 8, 12, 24, 36, and 48 hours postdose
Population: All allocated participants who received a dose of study intervention and had data available for CLr.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Panel A - Moderate Renal Impairment (RI) | Renal Clearance (CLr) of MK-0616 | 0.0573 Liter/hour |
| Panel B - Healthy Controls | Renal Clearance (CLr) of MK-0616 | 0.152 Liter/hour |
90% CI: [0.13, 1.13]