Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT01033318
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2009-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2008-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state', 'timeFrame': 'Through 32 hours postdose'}, {'measure': 'Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state', 'timeFrame': '24 hours postdose'}, {'measure': 'Part 2: Safety and tolerability of rising single oral doses of MK1809 in adult hypertensive patients based on an assessment of clinical and laboratory adverse experiences', 'timeFrame': 'Duration of study and up to 14 days after administration of the last dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Part 1: Area under the plasma concentration (AUC) versus time curve resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)', 'timeFrame': '24 hours postdose'}, {'measure': 'Part 1: Maximum concentration of drug in the plasma (Cmax) resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)', 'timeFrame': 'Through 32 hours postdose'}, {'measure': 'Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability', 'timeFrame': 'Duration of study and up to 14 days after administration of the last dose of study drug'}, {'measure': 'Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite', 'timeFrame': 'Through 32 hours postdose'}, {'measure': 'Part 2: Trough plasma concentration of the E3174 metabolite', 'timeFrame': 'Through 32 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart 1:\n\n* Nonsmoker for at least 6 months\n* Body Mass Index (BMI) less than or equal to 29 kg/m2\n* In overall good health\n\nPart 2:\n\n* Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2\n* In overall good health (patients with hypertension and/or hyperlipidemia are accepted)\n\nExclusion Criteria:\n\nPart 1:\n\n* History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years\n* History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder\n* History of cancer\n* Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)\n* Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)\n* History of asthma, severe wheezing, COPD, or other pulmonary disease\n* Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties\n* Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days\n* Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)\n* Nitrate therapy within 4 weeks\n* History of significant drug allergy or history of food allergies\n\nPart 2\n\n* History of any clinically significant cardiac or cardiovascular disease (other than hypertension)\n* History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder\n* History of cancer\n* History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)\n* Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)\n* History of asthma, severe wheezing, COPD, or other pulmonary disease\n* Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties\n* Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)\n* Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days\n* Nitrate therapy within 4 weeks\n* History of significant drug allergy'}, 'identificationModule': {'nctId': 'NCT01033318', 'briefTitle': 'A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Double Dummy, Randomized, Placebo-Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of MK1809 in Healthy Young Volunteers', 'orgStudyIdInfo': {'id': '1809-001'}, 'secondaryIdInfos': [{'id': 'MK1809-001'}, {'id': '2009_703'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 A-1', 'description': 'Part 1; Panel A; Sequence 1:\n\n2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 A-2', 'description': 'Part 1; Panel A; Sequence 2:\n\nLosartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 A-3', 'description': 'Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 A-4', 'description': 'Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 A-5', 'description': 'Part 1; Panel A; Sequence 5:\n\nPlacebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 B-1', 'description': 'Part 1; Panel B; Sequence 1:\n\n5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 B-2', 'description': 'Part 1; Panel B; Sequence 2:\n\n5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 B-3', 'description': 'Part 1; Panel B; Sequence 3:\n\n5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 B-4', 'description': 'Part 1; Panel B; Sequence 4:\n\nLosartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 B-5', 'description': 'Part 1; Panel B; Sequence 5:\n\nPlacebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 C-1', 'description': 'Part 2; Panel C; Sequence 1:\n\n50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 C-2', 'description': 'Part 2; Panel C; Sequence 2:\n\n50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 C-3', 'description': 'Part 2; Panel C; Sequence 3:\n\nLosartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 C-4', 'description': 'Part 2; Panel C; Sequence 4:\n\n50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 C-5', 'description': 'Part 2; Panel C; Sequence 5:\n\nPlacebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809', 'interventionNames': ['Drug: MK1809', 'Drug: Comparator: Losartan', 'Drug: Comparator: Placebo']}], 'interventions': [{'name': 'MK1809', 'type': 'DRUG', 'description': 'single oral doses of MK1809', 'armGroupLabels': ['Part 1 A-1', 'Part 1 A-2', 'Part 1 A-3', 'Part 1 A-4', 'Part 1 A-5', 'Part 1 B-1', 'Part 1 B-2', 'Part 1 B-3', 'Part 1 B-4', 'Part 1 B-5', 'Part 2 C-1', 'Part 2 C-2', 'Part 2 C-3', 'Part 2 C-4', 'Part 2 C-5']}, {'name': 'Comparator: Losartan', 'type': 'DRUG', 'otherNames': ['Losartan'], 'description': 'single oral doses of 100 mg Losartan', 'armGroupLabels': ['Part 1 A-1', 'Part 1 A-2', 'Part 1 A-3', 'Part 1 A-4', 'Part 1 A-5', 'Part 1 B-2', 'Part 1 B-3', 'Part 1 B-4', 'Part 1 B-5', 'Part 2 C-1', 'Part 2 C-2', 'Part 2 C-3', 'Part 2 C-4', 'Part 2 C-5']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo to MK1809', 'armGroupLabels': ['Part 1 A-1', 'Part 1 A-2', 'Part 1 A-3', 'Part 1 A-4', 'Part 1 A-5', 'Part 1 B-1', 'Part 1 B-2', 'Part 1 B-4', 'Part 1 B-5', 'Part 2 C-1', 'Part 2 C-2', 'Part 2 C-3', 'Part 2 C-4', 'Part 2 C-5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}