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| ID | Type | Description | Link |
|---|---|---|---|
| 618-REN-14-02 | Other Identifier | Cubist Study Number | |
| MK-6183-001 | Other Identifier | Merck Protocol Number |
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The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans. The study will also assess the safety profile and tolerability of MK-6183 in healthy participants, participants with varying degrees of renal impairment (RI), or participants with end-stage renal disease (ESRD) requiring hemodialysis (HD), based on estimated glomerular filtration rate (eGFR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Healthy | Experimental | Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2). |
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| Group B: Mild RI | Experimental | Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2). |
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| Group C: Moderate RI | Experimental | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2). |
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| Group D: Severe RI | Experimental | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2) not receiving HD. |
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| Group E: ESRD-HD | Experimental | Participants with ESRD who are receiving HD for at least 3 months preceding the initial dose in this study (Stage 5). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6183 | Drug | MK-6183 (CB-238,614) is supplied as lyophilized powder 500 mg vial and mixed into solution for 100 mL intravenous (IV) administration over 1 hour. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Last Measurable Concentration (AUC0-last) of MK-6183 | AUC0-last is the area under the plasma concentration-time curve from the time of dosing to the last post-dose measurable concentration. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | Groups A to D & Group E: Period 2: Pre-dose and 0.5, 1 (end of infusion; EOI), 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
| AUC From Dosing to ∞ (AUC0-∞) of MK-6183 | AUC0-∞ is the extrapolated area under the plasma concentration-time curve from the time of dosing to infinity. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and least squares (LS) mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared. | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
| Maximum Plasma Drug Concentration (Cmax) of MK-6183 | Cmax is the maximum observed post-dose drug concentration in plasma. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and LS mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. | Up to 12 days |
| Number of Participants Discontinuing From the Study Due to an AE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Healthy participants, participants with varying degrees of renal impairment (RI), and participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) (renal status was based on estimated glomerular filtration rate [eGFR]) were recruited at 2 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Healthy | Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. |
| FG001 | Group B: Mild RI | Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
| Apparent Total Body Clearance of MK-6183 From Plasma (CL) | CL is a measure of the clearance of drug from plasma via metabolism and excretion. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
| Volume of Distribution at Steady State (Vss) of MK-6183 | Vss is the apparent volume of distribution at steady state for MK-6183. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
| Apparent Plasma Half-life (t½) of MK-6183 | t½ is the amount of time required for the plasma concentration of MK-6183 to reduce by 50%. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
| Cumulative Amount of MK-6183 Excreted in Urine or Dialysate (Ae) | Ae is the cumulative amount of drug excreted unchanged in urine or dialysate. For Groups A, B, C, and D, Ae was assessed in urine. For Group E: Period 1, Ae was assessed in dialysate (participants in Group E had no detectable urine data) at hourly collection intervals during HD (HD commenced 3 hours after dosing). | Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD |
| Renal Clearance of MK-6183 (CLr) | CLr is the clearance of drug from plasma via the kidneys. Only data from Groups A, B, C, and D is presented; participants in Group E (Period 1) had no detectable urine data. Data for Group E: Period 1 are presented below in the dialysate clearance measure. | 0 to 24, 24 to 48, and 48 to 72 hours post-dose |
| Dialysate Clearance of MK-6183 (CLd) | CLd is the amount of drug cleared from plasma via dialysis. Only data collected during HD (Group E: Period 1) is presented (HD commenced 3 hours after dosing). | 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD |
| Fraction of the Administered Dose of MK-6183 Excreted Unchanged in Urine or Dialysate (Fe) | Fe is the fraction (percentage) of the administered dose that was excreted unchanged in urine (Groups A to D) or dialysate (Group E: Period 1; HD commenced 3 hours after dosing). | Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. |
| Up to 12 days |
| FG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| FG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| FG004 | Group E: ESRD-HD | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD [doses given 48 hours apart]). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Healthy | Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. |
| BG001 | Group B: Mild RI | Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. |
| BG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| BG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| BG004 | Group E: ESRD-HD | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD [doses given 48 hours apart]). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Last Measurable Concentration (AUC0-last) of MK-6183 | AUC0-last is the area under the plasma concentration-time curve from the time of dosing to the last post-dose measurable concentration. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values. | Posted | Mean | Standard Deviation | ug*hr/mL | Groups A to D & Group E: Period 2: Pre-dose and 0.5, 1 (end of infusion; EOI), 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
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| Secondary | Number of Participants Experiencing an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. | All treated participants are included. | Posted | Count of Participants | Participants | Up to 12 days |
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| Primary | AUC From Dosing to ∞ (AUC0-∞) of MK-6183 | AUC0-∞ is the extrapolated area under the plasma concentration-time curve from the time of dosing to infinity. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and least squares (LS) mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared. | All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values. | Posted | Mean | Standard Deviation | ug*hr/mL | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
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| Primary | Maximum Plasma Drug Concentration (Cmax) of MK-6183 | Cmax is the maximum observed post-dose drug concentration in plasma. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and LS mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared. | All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values. | Posted | Mean | Standard Deviation | ug/mL | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
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| Primary | Apparent Total Body Clearance of MK-6183 From Plasma (CL) | CL is a measure of the clearance of drug from plasma via metabolism and excretion. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values. | Posted | Mean | Standard Deviation | L/hour | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
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| Primary | Volume of Distribution at Steady State (Vss) of MK-6183 | Vss is the apparent volume of distribution at steady state for MK-6183. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values. | Posted | Mean | Standard Deviation | Liters | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
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| Primary | Apparent Plasma Half-life (t½) of MK-6183 | t½ is the amount of time required for the plasma concentration of MK-6183 to reduce by 50%. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. | All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values. | Posted | Mean | Standard Deviation | Hours | Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose |
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| Secondary | Number of Participants Discontinuing From the Study Due to an AE | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. | All treated participants are included. | Posted | Count of Participants | Participants | Up to 12 days |
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| Primary | Cumulative Amount of MK-6183 Excreted in Urine or Dialysate (Ae) | Ae is the cumulative amount of drug excreted unchanged in urine or dialysate. For Groups A, B, C, and D, Ae was assessed in urine. For Group E: Period 1, Ae was assessed in dialysate (participants in Group E had no detectable urine data) at hourly collection intervals during HD (HD commenced 3 hours after dosing). | All participants who received MK-6183 and had viable results are included. For Group E, only results from Period 1 are presented as Period 2 sampling occurred post-HD. | Posted | Mean | Standard Deviation | mg | Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD |
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| Primary | Renal Clearance of MK-6183 (CLr) | CLr is the clearance of drug from plasma via the kidneys. Only data from Groups A, B, C, and D is presented; participants in Group E (Period 1) had no detectable urine data. Data for Group E: Period 1 are presented below in the dialysate clearance measure. | All participants who received MK-6183 and had viable results are included. CLr data are not presented for Group E. | Posted | Mean | Standard Deviation | Liters/hour | 0 to 24, 24 to 48, and 48 to 72 hours post-dose |
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| Primary | Dialysate Clearance of MK-6183 (CLd) | CLd is the amount of drug cleared from plasma via dialysis. Only data collected during HD (Group E: Period 1) is presented (HD commenced 3 hours after dosing). | All participants who received MK-6183 and had viable results are included. Only data for Group E: Period 1 is presented. | Posted | Mean | Standard Deviation | Liters/hour | 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD |
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| Primary | Fraction of the Administered Dose of MK-6183 Excreted Unchanged in Urine or Dialysate (Fe) | Fe is the fraction (percentage) of the administered dose that was excreted unchanged in urine (Groups A to D) or dialysate (Group E: Period 1; HD commenced 3 hours after dosing). | All participants who received MK-6183 and had viable results are included. | Posted | Mean | Standard Deviation | mg | Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD |
|
Up to 12 days
All treated participants are included. Data from Group E: Period 1 and Group E: Period 2 are combined.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Healthy | Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG001 | Group B: Mild RI | Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG004 | Group E: ESRD-HD | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose in this study (Stage 5) received MK-6183 250 mg as a 1-hour infusion twice (once prior to HD and once after HD [doses given 48 hours apart]). | 0 | 8 | 0 | 8 | 4 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Somnambulism | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| Male |
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| OG004 | Group E: ESRD-HD Periods 1 and 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as 2 1-hour infusions (1 before HD and 1 after HD). |
|
|
Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. |
| OG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
| OG005 | Group E: ESRD-HD Period 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD). |
|
|
|
Participants with mild RI (Stage 2: eGFR ≥60 to <90 mL/min/1.73m^2) received MK-6183 1 g as a 1-hour IV infusion. |
| OG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
| OG005 | Group E: ESRD-HD Period 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD). |
|
|
|
| OG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
| OG005 | Group E: ESRD-HD Period 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD). |
|
|
| OG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
| OG005 | Group E: ESRD-HD Period 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD). |
|
|
| OG002 | Group C: Moderate RI | Participants with moderate RI (Stage 3: eGFR ≥30 to <60 mL/min/1.73m^2) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
| OG005 | Group E: ESRD-HD Period 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB,238-615 250 mg as a 1-hour infusion within 2 hours of completing HD in Period 2 (Period 2 HD commenced 2 days after completing Period 1 HD). |
|
|
| OG004 | Group E: ESRD-HD Periods 1 and 2 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as 2 1-hour infusions (1 before HD and 1 after HD). |
|
|
| OG003 | Group D: Severe RI | Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
|
|
Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion.
|
|
|
Participants with severe RI (Stage 4: eGFR <30 mL/min/1.73m^2 [not receiving HD]) received MK-6183 500 mg as a 1-hour IV infusion. |
| OG004 | Group E: ESRD-HD Period 1 | Participants with ESRD who underwent HD for at least 3 months preceding the initial dose of study drug (Stage 5) received CB-238,615 250 mg as a 1-hour infusion prior to undergoing HD in Period 1. Both plasma and dialysate samples were collected during Period 1. |
|
|