Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-13 @ 3:33 AM
Study NCT ID:
NCT00513994
Status:
COMPLETED
Last Update Posted:
2008-04-11
First Post:
2007-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-08', 'studyFirstSubmitDate': '2007-08-07', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is the measurement and comparison of the levels of nitroglycerin and its metabolites in the blood of healthy human volunteers after a single topical dose of MQX-503 and a single topical dose of Nitroglycerin Ointment 2%, USP.', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'A secondary objective is the observation of the volunteers for any adverse events', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Nitroglycerin', 'pharmacokinetics study of nitroglycerin containing treatments'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers 18 - 70 years of age.\n* Subjects able to give written informed consent and comply with study requirements.\n* Subjects willing and able to safely discontinue all current prescription therapies.\n* Subjects who will agree not to participate in other clinical trials.\n* Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Persons who would be put at risk by discontinuing prescription therapies.\n* Subjects with a known allergy to nitroglycerin.\n* Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.\n* Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.\n* Subjects who have participated in a study of an investigational drug within two weeks of visit 1.\n* Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.\n* Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.\n* Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.\n* Pregnant or nursing women.\n* Women of childbearing potential who are unwilling to comply with the contraceptive requirements."}, 'identificationModule': {'nctId': 'NCT00513994', 'briefTitle': 'MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediQuest Therapeutics'}, 'officialTitle': 'MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects', 'orgStudyIdInfo': {'id': '07-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Nitroglycerin']}], 'interventions': [{'name': 'Nitroglycerin', 'type': 'DRUG', 'otherNames': ['MQX-503, Nitro-Bid'], 'description': 'MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Charles River Clinical Services', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Adel Nada, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles River Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediQuest Therapeutics', 'class': 'INDUSTRY'}}}}