Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01409369
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002606', 'term': 'Charcoal'}], 'ancestors': [{'id': 'D002244', 'term': 'Carbon'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C max: maximum observed plasma concentration', 'timeFrame': '18 weeks'}, {'measure': 'T max: time of maximum observed plasma concentration', 'timeFrame': '18 weeks'}, {'measure': 'T1/2: apparent terminal half-life', 'timeFrame': '18 weeks'}, {'measure': 'AUC: area under the plasma concentration-time curve', 'timeFrame': '18 weeks'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects, 18 to 65 years of age, inclusive\n* Body mass index (BMI) 18 to 30 kg/m2 inclusive\n* All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug\n* Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.\n\nExclusion Criteria:\n\n* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse\n* Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2\n* Participation in an investigational drug or device study within 3 months prior to first administration of the study drug\n* Any confirmed allergic reaction against any drug or multiple allergies\n* Dietary restrictions that would prohibit the consumption of standardized meals\n* Positive cotinine test and/or any use of nicotine containing products\n* Clinically relevant history of constipation or bowel disorder\n* Known intolerability to activated charcoal'}, 'identificationModule': {'nctId': 'NCT01409369', 'briefTitle': 'A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'BP25485'}, 'secondaryIdInfos': [{'id': '2011-000916-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RO4995819', 'Drug: activated charcoal']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: RO4995819']}], 'interventions': [{'name': 'RO4995819', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['1', '2']}, {'name': 'activated charcoal', 'type': 'DRUG', 'description': 'orally 3 times daily, Days 1-7', 'armGroupLabels': ['1']}]}, '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'}}}}