Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT01367535
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2011-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C032257', 'term': 'methylnaltrexone'}, {'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentration of MNTX', 'timeFrame': '4 months', 'description': 'The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration of Paroxetine', 'timeFrame': '4 months', 'description': 'The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy males between the ages of 18 and 55\n2. Non-Smokers\n3. Body weight range form 154-220 lbs\n4. No history of clinically significant metabolic disorders.\n\nExclusion Criteria:\n\n1. Any history of low CYP450 2D6 activity\n2. History of alcohol abuse or recreational drugs\n3. History of any clinically significant disease or condition affecting a major organ system\n4. Donation or loss of blood, 60 days proceeding to screening visit.'}, 'identificationModule': {'nctId': 'NCT01367535', 'briefTitle': 'Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan', 'orgStudyIdInfo': {'id': 'MNTX 1108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: SC Methylnaltrexone (MNTX)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: IV Methylnaltrexone (MNTX)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Oral Paroxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 4', 'interventionNames': ['Drug: SC Placebo']}], 'interventions': [{'name': 'SC Methylnaltrexone (MNTX)', 'type': 'DRUG', 'armGroupLabels': ['Arm 1']}, {'name': 'IV Methylnaltrexone (MNTX)', 'type': 'DRUG', 'armGroupLabels': ['Arm 2']}, {'name': 'Oral Paroxetine', 'type': 'DRUG', 'armGroupLabels': ['Arm 3']}, {'name': 'SC Placebo', 'type': 'DRUG', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Progenics Pharmaceuticals', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}], 'overallOfficials': [{'name': 'Tage Ramakrishna, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Progenics Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Tage Ramakrishna, M.D.;', 'oldOrganization': 'Progenics Pharmaceuticals, Inc.'}}}}