Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT01367756
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015283', 'term': 'Citalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-05-30', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'up to 58 days'}], 'secondaryOutcomes': [{'measure': 'Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram', 'timeFrame': '17 days'}, {'measure': 'Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram', 'timeFrame': 'up to 58 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)\n* Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive\n* Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug\n* Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)\n* Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2\n* Hepatitis B, hepatitis C or HIV infection\n* Smokers of \\>5 cigarettes or equivalent tobacco intake per day\n* Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)\n* Participation in an investigational drug or device study within 3 months prior to dosing'}, 'identificationModule': {'nctId': 'NCT01367756', 'briefTitle': 'A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BP25679'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RO4995819', 'Drug: citalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: citalopram', 'Drug: placebo']}], 'interventions': [{'name': 'RO4995819', 'type': 'DRUG', 'description': 'multiple oral doses, Days 10-16', 'armGroupLabels': ['1']}, {'name': 'citalopram', 'type': 'DRUG', 'description': 'multiple oral doses, Days 1-16', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'multiple oral doses, Days 10-16', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67064', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}