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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5684-010 | Other Identifier | MSD | |
| CA43216 | Other Identifier | Celerion |
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The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Severe Renal Impairment (RI) | Experimental | Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal). |
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| Group 2: End-stage renal disease (ESRD) | Experimental | Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) in Period 1 and Period 2. In Period 1, participants will receive a single oral dose of MK-5684 approximately 30 minutes prior to their normally scheduled hemodialysis (HD), followed by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. In Period 2, participants will receive a single oral dose of MK-5684 immediately followed by completion of their normally scheduled HD, and by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. |
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| Group 3: Healthy Participants | Experimental | Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-5684 | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684 | Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 hours post-dose |
| Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684 | Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 hours post-dose |
| Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684 | Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 24 hours post-dose |
| Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684 | Blood samples will be collected to determine the Cmax of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 hours post-dose |
| Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684 | Blood samples will be collected to determine the Tmax of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 hours post-dose |
| Apparent Terminal Half-Life (t½) of MK-5684 | Blood samples will be collected to determine the t1/2 of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 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 the study intervention, whether or not considered related to the study intervention. | Up to ~21 days |
| Number of Participants who Discontinue Study Intervention Due to an AE |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to:
All Participants
Participants with severe renal impairment (RI) (Group 1):
Participants with end-stage renal disease (ESRD) (Group 2):
Healthy Control Participants (Group 3):
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
All Participants:
Participants with Severe RI (Group 1):
Participants with ESRD (Group 2):
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center ( Site 0002) | Orlando | Florida | 32809 | United States | ||
| Research by Design ( Site 0001) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Prednisone | Drug | Oral tablet |
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| Fludrocortisone acetate | Drug | Oral tablet |
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| Apparent Clearance (CL/F) of MK-5684 | Blood samples will be collected to determine the CL/F of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 hours post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684 | Blood samples will be collected to determine the Vz/F of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 72 hours post-dose |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Up to ~7 days |
| Dialysis Clearance (CLD) of MK5684 Based on Plasma | Dialysate will be collected to determine the CLD of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 4.5 hours post-dose |
| Concentration of Dialysate (CD) of MK-5684 Samples | Dialysate will be collected to determine the CD of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 4.5 hours post-dose |
| Amount of drug (AD) of MK-5684 recovered from each dialysate collection | Dialysate will be collected to determine the AD of MK-5684 in plasma. | At protocol specific time points pre-dose and up to 4.5 hours post-dose |
| Chicago |
| Illinois |
| 60643 |
| United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C034635 | fludrocortisone acetate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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