Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-01-25 @ 6:00 PM
Study NCT ID:
NCT00868361
Status:
TERMINATED
Last Update Posted:
2009-09-16
First Post:
2009-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Absorption, Metabolism and Excretion of Talampanel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C085266', 'term': 'talampanel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'whyStopped': 'Poor recruitment of fast and slow acetylators', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-15', 'studyFirstSubmitDate': '2009-03-24', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the mass balance of [14C]-talampanel. To characterize the metabolism of [14C] talampanel in plasma, feces, and urine. To assess the pharmacokinetics (PK) of total radioactivity, talampanel, and N-acetyl talampanel.', 'timeFrame': '6-9 days'}], 'secondaryOutcomes': [{'measure': 'To explore the effect of N-acetyltransferase 2 (NAT2) genotype on the PK and metabolism of [14C] talampanel. To further assess the safety and tolerability of talampanel.', 'timeFrame': '6-9 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mass Balance', 'Talampanel', 'Pharmacokinetics', 'Metabolism', 'Metabolites', 'Healthy Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the chemical breakdown and excretion of talampanel and its break down products in plasma, feces, and urine of healthy human volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males, between 18 and 55 years of age, inclusive\n* Body Mass Index range 18.0 to 30.0 kg/m2, inclusive\n* Have NAT2 slow or rapid acetylator genotype\n* In good health as determined by the investigator\n* Negative test for selected drugs of abuse at screening\n* Negative screens for Hepatitis B, Hepatitis C and HIV\n* Sterile or agrees to use an approved method of contraception from Check-in until 45 days following Clinic Discharge\n* Able to comprehend and willing to sign an Informed Consent Form\n* Have 1 to 2 bowel movements per day\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any significant metabolic, allergic, skin, liver, kidney, blood, heart or blood vessel, digestive system, brain or psychiatric disorder\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* History of stomach or intestinal surgery or resection\n* History or presence of an abnormal ECG,\n* History of clinically significant alcohol or drug use within 1 year prior to Check-in\n* Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in\n* Exposure to significant radiation within 12 months prior to Check-in -Use of any tobacco- or nicotine-containing within 6 months prior to Check- in\n* Use of any drugs which may interact with the study drug within 30 days prior to Check-in\n* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in\n* Use of any prescription medications/products within 14 days prior to Check in\n* Use of any over-the-counter, non-prescription drugs within 7 days prior to Check-in\n* Use of grapefruit or grapefruit-containing foods or beverages within 7 days prior to Check-in\n* Use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to Check-in\n* Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion\n* Receipt of blood products within 2 months prior to Check-in\n* Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study"}, 'identificationModule': {'nctId': 'NCT00868361', 'briefTitle': 'A Study to Investigate the Absorption, Metabolism and Excretion of Talampanel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase 1 Open-label Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Talampanel Following Oral Administration to Healthy Male', 'orgStudyIdInfo': {'id': 'TAL-MB-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow and rapid N-acetyl transferase genotypes', 'interventionNames': ['Drug: Talampanel (non-radiolabeled), [14C] Talampanel']}], 'interventions': [{'name': 'Talampanel (non-radiolabeled), [14C] Talampanel', 'type': 'DRUG', 'otherNames': ['TV-7600'], 'description': '50 mg capsule single dose', 'armGroupLabels': ['Slow and rapid N-acetyl transferase genotypes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Pharmacology Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Nicholas M Siebers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Covance', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Siyu Liu, M.D., Ph.D.', 'oldOrganization': 'Vice President, Innovative Research and Development and Head of Global Clinical Operations'}}}}