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| ID | Type | Description | Link |
|---|---|---|---|
| MK-2828-006 | Other Identifier | MSD |
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The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Renal Impairment | Experimental | Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1 |
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| End Stage Renal Disease (ESRD) on Hemodialysis (HD) | Experimental | Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses. |
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| Healthy Mean Matched Control | Experimental | Participants with normal renal function will receive a single dose of MK-2828 on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-2828 | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma | Blood samples will be collected to determine the AUC0-inf of MK-2828 | Pre dose and at designated time points up to 192 hours post dose |
| Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma | Blood samples will be collected to determine the AUC0-last of MK-2828 | Pre dose and at designated time points up to 192 hours post dose |
| Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma | Blood samples will be collected to determine the AUC0-24 of MK-2828 | Pre dose and at designated time points up to 24 hours post dose |
| Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma | Blood samples will be collected to determine the Cmax of MK-2828 | Pre dose and at designated time points up to 192 hours post dose |
| Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma | Blood samples will be collected to determine the Tmax of MK-2828 | Pre dose and at designated time points up to 192 hours post dose |
| Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma | Blood samples will be collected to determine the C24 of MK-2828 | At designated time points up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. The number of participants who experience an AE will be reported. | Up to approximately 14 days |
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The main inclusion criteria include but are not limited to the following:
Severe Renal Impairment Participants:
ESRD on HD Participants:
The main exclusion criteria include but are not limited to the following:
Renal Impairment Participants:
Healthy Matched Control Participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panax Clinical Research ( Site 0003) | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma |
Blood samples will be collected to determine the t1/2 of MK-2828 |
| Pre dose and at designated time points up to 192 hours post dose |
| Apparent Total Plasma Clearance (CL/F) of MK-2828 | Blood samples will be collected to determine the CL/F of MK-2828 | Pre dose and at designated time points up to 192 hours post dose |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of MK-2828 in Plasma | Blood samples will be collected to determine the Vz/F of MK-2828 | Pre dose and at designated time points up to 192 hours post dose |
| Number of Participants Who Discontinue Study Intervention Due to an AE | 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. The number of participants who experience an AE will be reported. | Up to approximately 2 days |
| Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828 | Blood samples will be collected to determine the AUCD of MK-2828 | Prior to hemodialysis (HD) and at designated time points until day 6 |
| Area Under the Concentration-time Curve Determined from the Pre-dialyzer Line (AUCCa) of MK-2828 | Blood samples will be collected to determine the during AUCCa of MK-2828 during the dialysis period | Prior to hemodialysis (HD) and at designated time points until day 6 |
| Area Under the Concentration-time Curve Determined from the Post-dialyzer Line (AUCCv) of MK-2828 | Blood samples will be collected to determine the during AUCCv of MK-2828 during the dialysis period | Prior to hemodialysis (HD) and at designated time points until day 6 |
| Dialysis Clearance (CLD) of MK-2828 Based on Plasma | Blood samples will be collected to determine the CLD of MK-2828 based on plasma during the dialysis period | Prior to hemodialysis (HD) and at designated time points until day 6 |
| Hemodialysis Extraction Ratio (ER_D) of MK-2828 | Blood samples will be collected to determine the ER_D of MK-2828 during the dialysis period | Prior to hemodialysis (HD) and at designated time points until day 6 |
| Floridian Clinical Research ( Site 0001) | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Orlando Clinical Research Center ( Site 0002) | Recruiting | Orlando | Florida | 32809 | United States |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |