Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 5:50 PM
Study NCT ID:
NCT01636492
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2012-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550631', 'term': '(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2012-07-06', 'studyFirstSubmitQcDate': '2012-07-06', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': '17 days'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Area under the concentration-time curve', 'timeFrame': 'Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose'}, {'measure': 'Pharmacokinetics: Urine concentrations drug/metabolites', 'timeFrame': 'Pre-dose and up to 72 hours post-dose'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male healthy volunteer, 18 to 60 years of age inclusive\n* Body mass index (BMI) 19-35 kg/m2 inclusive\n* Supine blood pressure within the normal range of the center and heart rate \\>/= 40 provided QTcB is \\<450 ms\n* Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion\n\nExclusion Criteria:\n\n* History or evidence of any clinically significant disease or disorder\n* Clinically significant ECG abnormalities\n* Positive for hepatitis B, hepatitis C or HIV infection\n* Previous treatment with iron for iron deficiency anemia\n* Regular smoker (\\>10 cigarettes, \\>3 pipefuls or \\>3 cigars per day)\n* History of alcohol and/or drug abuse or addiction within the last 2 years before study start\n* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator\n* Participation in a clinical study with an investigational drug within the last three months prior to screening\n* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee'}, 'identificationModule': {'nctId': 'NCT01636492', 'briefTitle': 'A Study of Bitopertin (RO4917838) in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.', 'orgStudyIdInfo': {'id': 'BP19292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bitopertin', 'interventionNames': ['Drug: bitopertin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'bitopertin', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Bitopertin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}