Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT01832103
Status:
WITHDRAWN
Last Update Posted:
2013-09-24
First Post:
2013-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619418', 'term': 'MK-7145'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration', 'timeFrame': 'Up to 48 Hours Post Dose'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration', 'timeFrame': 'Up to 48 Hours Post Dose'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration', 'timeFrame': 'Up to 48 Hours Post Dose'}, {'measure': 'Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration', 'timeFrame': 'Up to 48 Hours Post Dose'}, {'measure': 'Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration', 'timeFrame': 'Up to 24 Hours Post Dose'}, {'measure': 'Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration', 'timeFrame': 'Up to 48 Hours Post Dose'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)', 'timeFrame': '24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) 18 to 35 kg/m\\^2\n* Nonsmoker and/or have not used nicotine or nicotine-containing products\n\nfor at least 3 months prior to enrollment\n\n* Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m\\^2\n\nExclusion Criteria:\n\n* History of stroke, chronic seizures, or major neurological disorder\n* Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular,\n\nhematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases\n\n* Systolic blood pressure (SBP) ≤95 mmHg or \\>160 mmHg, or diastolic blood\n\npressure (DBP) ≤45 mmHg or \\>95 mmHg\n\n* History of neoplastic disease except for adequately treated non-melanomatous skin carcinoma\n* Unable to refrain from, or anticipates the use of, strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors\n* Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, wine, or distilled spirits per day\n* Consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day\n* Had major surgery or donated blood within 8 weeks prior to enrollment\n* Has participated in another investigational study within 4 weeks prior\n* History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food\n* Currently a regular user of illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months\n* Has active or has a history of nephrolithiasis\n* Has had a kidney removed or has a functioning renal transplant'}, 'identificationModule': {'nctId': 'NCT01832103', 'briefTitle': 'The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency', 'orgStudyIdInfo': {'id': '7145-018'}, 'secondaryIdInfos': [{'id': '2013-000838-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-7145', 'description': 'MK-7145 2 mg IR administered as a single oral dose.', 'interventionNames': ['Drug: MK-7145']}], 'interventions': [{'name': 'MK-7145', 'type': 'DRUG', 'armGroupLabels': ['MK-7145']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}