Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT01629368
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'C000596770', 'term': '2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-06-25', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area under the concentration time curve', 'timeFrame': 'Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29'}], 'secondaryOutcomes': [{'measure': 'Safety: incidence of adverse events', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, 18-65 years of age inclusive\n* Non-smokers\n* Body mass index (BMI) between 18 and 30 mg/m2 inclusive\n* Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception\n\nExclusion Criteria:\n\n* Evidence of any active or chronic disease\n* History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer\n* History or presence of clinically significant psychiatric condition\n* Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study'}, 'identificationModule': {'nctId': 'NCT01629368', 'briefTitle': 'A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BP28256'}, 'secondaryIdInfos': [{'id': '2012-000771-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosing Period 1', 'interventionNames': ['Drug: RO4917523']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing Period 2', 'interventionNames': ['Drug: Carbamazepine', 'Drug: RO4917523']}], 'interventions': [{'name': 'Carbamazepine', 'type': 'DRUG', 'description': 'Multiple doses of carbamazepine', 'armGroupLabels': ['Dosing Period 2']}, {'name': 'RO4917523', 'type': 'DRUG', 'description': 'Single dose of RO4917523', 'armGroupLabels': ['Dosing Period 1', 'Dosing Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35042', 'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}