Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-30 @ 3:42 PM
Study NCT ID:
NCT06814132
Status:
COMPLETED
Last Update Posted:
2025-10-23
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C034635', 'term': 'fludrocortisone acetate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma.'}, {'measure': 'Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma.'}, {'measure': 'Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 24 hours post-dose', 'description': 'Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma.'}, {'measure': 'Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the Cmax of MK-5684 in plasma.'}, {'measure': 'Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the Tmax of MK-5684 in plasma.'}, {'measure': 'Apparent Terminal Half-Life (t½) of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the t1/2 of MK-5684 in plasma.'}, {'measure': 'Apparent Clearance (CL/F) of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the CL/F of MK-5684 in plasma.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684', 'timeFrame': 'At protocol specific time points pre-dose and up to 72 hours post-dose', 'description': 'Blood samples will be collected to determine the Vz/F of MK-5684 in plasma.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants who Experience an Adverse Event (AE)', 'timeFrame': 'Up to ~21 days', 'description': '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.'}, {'measure': 'Number of Participants who Discontinue Study Intervention Due to an AE', 'timeFrame': 'Up to ~7 days', 'description': '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.'}, {'measure': 'Dialysis Clearance (CLD) of MK5684 Based on Plasma', 'timeFrame': 'At protocol specific time points pre-dose and up to 4.5 hours post-dose', 'description': 'Dialysate will be collected to determine the CLD of MK-5684 in plasma.'}, {'measure': 'Concentration of Dialysate (CD) of MK-5684 Samples', 'timeFrame': 'At protocol specific time points pre-dose and up to 4.5 hours post-dose', 'description': 'Dialysate will be collected to determine the CD of MK-5684 in plasma.'}, {'measure': 'Amount of drug (AD) of MK-5684 recovered from each dialysate collection', 'timeFrame': 'At protocol specific time points pre-dose and up to 4.5 hours post-dose', 'description': 'Dialysate will be collected to determine the AD of MK-5684 in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Failure, Chronic', 'End-Stage Kidney Disease', 'Renal Failure, Chronic', 'Renal Failure, End-Stage', 'Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\nAll Participants\n\n* Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing\n* Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m\\^2 at the screening visit\n\nParticipants with severe renal impairment (RI) (Group 1):\n\n* Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation\n\nParticipants with end-stage renal disease (ESRD) (Group 2):\n\n* Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit\n\nHealthy Control Participants (Group 3):\n\n* Has normal renal function\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\nAll Participants:\n\n* Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection\n* Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)\n* Has a history of cancer (malignancy)\n* Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)\n\nParticipants with Severe RI (Group 1):\n\n* Has a history or presence of renal artery stenosis\n* Has had a renal transplant\n* Has ESRD requiring HD\n\nParticipants with ESRD (Group 2):\n\n* Has required frequent emergent HD (≥ 3) within a year prior to the first dosing\n* Has a history or presence of renal artery stenosis.\n* Has had a functioning renal transplant within the past 2 years'}, 'identificationModule': {'nctId': 'NCT06814132', 'briefTitle': 'A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease', 'orgStudyIdInfo': {'id': '5684-010'}, 'secondaryIdInfos': [{'id': 'MK-5684-010', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'CA43216', 'type': 'OTHER', 'domain': 'Celerion'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Severe Renal Impairment (RI)', 'description': '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).', 'interventionNames': ['Drug: MK-5684', 'Drug: Prednisone', 'Drug: Fludrocortisone acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: End-stage renal disease (ESRD)', 'description': '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.', 'interventionNames': ['Drug: MK-5684', 'Drug: Prednisone', 'Drug: Fludrocortisone acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Healthy Participants', 'description': '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).', 'interventionNames': ['Drug: MK-5684', 'Drug: Prednisone', 'Drug: Fludrocortisone acetate']}], 'interventions': [{'name': 'MK-5684', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['Group 1: Severe Renal Impairment (RI)', 'Group 2: End-stage renal disease (ESRD)', 'Group 3: Healthy Participants']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['HRT'], 'description': 'Oral tablet', 'armGroupLabels': ['Group 1: Severe Renal Impairment (RI)', 'Group 2: End-stage renal disease (ESRD)', 'Group 3: Healthy Participants']}, {'name': 'Fludrocortisone acetate', 'type': 'DRUG', 'otherNames': ['HRT'], 'description': 'Oral tablet', 'armGroupLabels': ['Group 1: Severe Renal Impairment (RI)', 'Group 2: End-stage renal disease (ESRD)', 'Group 3: Healthy Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center ( Site 0002)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60643', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research by Design ( Site 0001)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}