A Phase 1 interventional study of MK-6183 in Healthy Volunteers and Renal Impairment, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 1, Interventional, and Treatment
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).
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 40 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 65 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Healthy participants with normal renal function (Stage 1: eGFR ≥90 mL/min/1.73m\^2).
Drug: MK-6183
Participants with mild RI (Stage 2: eGFR ≥60 to \<90 mL/min/1.73m\^2).
Drug: MK-6183
Participants with moderate RI (Stage 3: eGFR ≥30 to \<60 mL/min/1.73m\^2).
Drug: MK-6183
Participants with severe RI (Stage 4: eGFR \<30 mL/min/1.73m\^2) not receiving HD.
Drug: MK-6183
Participants with ESRD who are receiving HD for at least 3 months preceding the initial dose in this study (Stage 5).
Drug: MK-6183
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.
Also known as: CB-238,618
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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
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.
Time frame: Up to 12 days
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.
Time frame: Up to 12 days
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.
| Milestone | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD |
|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| ug*hr/mL | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 | Group E: ESRD-HD Period 2 |
|---|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Last Measurable Concentration (AUC0-last) of MK-6183 | 87.6 ± 8.49 | 114.8 ± 23.20 | 97.5 ± 25.71 | 228.0 ± 63.24 | 77.4 ± 8.79 | 270.6 ± 76.70 |
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.
| Participants | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Periods 1 and 2 |
|---|---|---|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | 4 | 2 | 2 | 3 | 4 |
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.
| ug*hr/mL | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 | Group E: ESRD-HD Period 2 |
|---|---|---|---|---|---|---|
| AUC From Dosing to ∞ (AUC0-∞) of MK-6183 | 87.8 ± 8.43 | 115.1 ± 23.44 | 97.8 ± 25.70 | 228.6 ± 63.44 | 86.8 ± 7.63 | 296.3 ± 78.66 |
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.
| ug/mL | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 | Group E: ESRD-HD Period 2 |
|---|---|---|---|---|---|---|
| Maximum Plasma Drug Concentration (Cmax) of MK-6183 | 45.3 ± 5.23 | 47.2 ± 8.19 | 24.2 ± 5.95 | 30.8 ± 3.90 | 12.9 ± 4.60 | 15.6 ± 6.59 |
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.
| L/hour | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 | Group E: ESRD-HD Period 2 |
|---|---|---|---|---|---|---|
| Apparent Total Body Clearance of MK-6183 From Plasma (CL) | 11.5 ± 1.23 | 9.0 ± 1.65 | 5.5 ± 1.64 | 2.4 ± 0.96 | 2.9 ± 0.26 | 0.9 ± 0.30 |
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.
| Liters | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 | Group E: ESRD-HD Period 2 |
|---|---|---|---|---|---|---|
| Volume of Distribution at Steady State (Vss) of MK-6183 | 21.4 ± 2.64 | 22.8 ± 4.43 | 23.9 ± 6.03 | 19.4 ± 2.55 | 52.1 ± 16.57 | 25.3 ± 8.33 |
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.
| Hours | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 | Group E: ESRD-HD Period 2 |
|---|---|---|---|---|---|---|
| Apparent Plasma Half-life (t½) of MK-6183 | 2.1 ± 0.45 | 2.8 ± 0.33 | 4.0 ± 1.28 | 6.8 ± 1.90 | 18.1 ± 3.79 | 19.2 ± 5.04 |
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.
| Participants | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Periods 1 and 2 |
|---|---|---|---|---|---|
| Number of Participants Discontinuing From the Study Due to an AE | 0 | 0 | 0 | 0 | 0 |
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).
| mg | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 |
|---|---|---|---|---|---|
| Cumulative Amount of MK-6183 Excreted in Urine or Dialysate (Ae) | 840.5 ± 65.33 | 699.1 ± 234.69 | 360.0 ± 33.82 | 309.1 ± 51.30 | 122.9 ± 29.21 |
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.
| Liters/hour | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI |
|---|---|---|---|---|
| Renal Clearance of MK-6183 (CLr) | 9.6 ± 1.14 | 6.1 ± 2.13 | 4.0 ± 1.61 | 1.7 ± 1.07 |
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).
| Liters/hour | Group E: ESRD-HD Period 1 |
|---|---|
| Dialysate Clearance of MK-6183 (CLd) | 1.4 ± 0.42 |
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).
| mg | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD Period 1 |
|---|---|---|---|---|---|
| Fraction of the Administered Dose of MK-6183 Excreted Unchanged in Urine or Dialysate (Fe) | 84.0 ± 6.53 | 69.9 ± 23.47 | 72.0 ± 6.76 | 61.8 ± 10.26 | 49.2 ± 11.68 |
Collected over Up to 12 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Healthy | 0/8 (0%) | 0/8 (0%) | 4/8 (50%) |
| Group B: Mild RI | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Group C: Moderate RI | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Group D: Severe RI | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Group E: ESRD-HD | 0/8 (0%) | 0/8 (0%) | 4/8 (50%) |
| Event | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD |
|---|---|---|---|---|---|
| HeadacheNervous system disorders | 0/8 | 0/8 | 0/8 | 1/8 | 2/8 |
| PalpitationsCardiac disorders | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 |
| Infusion site erythemaGeneral disorders | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 |
| Infusion site painGeneral disorders | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 |
| ParonychiaInfections and infestations | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 |
| RhinitisInfections and infestations | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/8 | 1/8 | 0/8 | 1/8 | 0/8 |
| Joint swellingMusculoskeletal and connective tissue disorders | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 |
| Balance disorderNervous system disorders | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 |
| Age, Continuous(Years) | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD | Total |
|---|---|---|---|---|---|---|
| Mean | 55.3 ± 2.43 | 63.8 ± 11.16 | 69.1 ± 4.88 | 65.3 ± 10.47 | 55.1 ± 7.55 | 61.7 ± 44.81 |
| Sex: Female, Male(Participants) | Group A: Healthy | Group B: Mild RI | Group C: Moderate RI | Group D: Severe RI | Group E: ESRD-HD | Total |
|---|---|---|---|---|---|---|
| Female | 2 | 3 | 1 | 4 | 1 | 11 |
| Male | 6 | 5 | 7 | 4 | 7 | 29 |
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Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)