Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT01495104
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2011-12-16', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC)', 'timeFrame': 'Period 2, day 10 and day 15'}, {'measure': 'Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC)', 'timeFrame': 'Period 1, day 5 and Period 2, Day 15'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': '16 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers, 18 to 65 years of age inclusive\n* Body mass index (BMI) 18 to 30 kg/m2 inclusive\n* Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)\n* Non smoker or smoker of fewer than 10 cigarettes per day\n\nExclusion Criteria:\n\n* History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study\n* Alcohol consumption averaging more than 24 g of alcohol per day\n* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer\n* Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1\n* Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer'}, 'identificationModule': {'nctId': 'NCT01495104', 'briefTitle': 'A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE VALPROATE ON THE PHARMACOKINETICS OF RO4917838 AND VICE VERSA IN HEALTHY MALE VOLUNTEERS', 'orgStudyIdInfo': {'id': 'BP25258'}, 'secondaryIdInfos': [{'id': '2011-002256-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: RO4917838', 'Drug: valproate']}], 'interventions': [{'name': 'RO4917838', 'type': 'DRUG', 'description': 'Multiple doses', 'armGroupLabels': ['Single Arm']}, {'name': 'valproate', 'type': 'DRUG', 'description': 'Multiple doses', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92502', 'city': 'Rueil-Malmaison', 'country': 'France', 'geoPoint': {'lat': 48.8765, 'lon': 2.18967}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}