Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT01356550
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)', 'timeFrame': '22 days'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': '29 days'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral:\n\n* Body mass index (BMI) between 18 and 32 kg/m2 inclusive\n\nHealthy Subjects:\n\n* Adult male or female subjects, 18-70 years of age\n\nHepatically impaired patients:\n\n* Adult patients, 18-65 years of age\n* Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C)\n* Hepatic impairment should be primary and must not be a complication of an underlying primary disease\n\nExclusion Criteria:\n\nGeneral:\n\n* Pregnant or lactating women\n* Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1\n* Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator\n* Positive for HIV infection\n* Renal insufficiency\n\nHealthy volunteers:\n\n* History of significant disease, or evidence of disease or condition which could interfere with the study or relapse during or immediately after the study\n* Any history of depressive episodes or treatment with antidepressants\n* Alcohol consumption averaging more than 2 units (16 g) of alcohol for females or 3 units (24 g) for males per day, or positive alcohol breath test at screening/Day -1\n* Positive for hepatitis B and/or hepatitis C infection\n\nHepatically impaired patients:\n\n* Evidence of unstable clinically significant disease other than impaired hepatic function, or condition or disease which could interfere with the study or relapse during or immediately after the study\n* Episode of acute depression within the last 6 months or current or previous (within the last 6 months) antidepressant treatment\n* Hepatocellular carcinoma or acute hepatic disease caused by infection or drug toxicity\n* Presence of surgically created or transjugular intrahepatic portal systemic shunts\n* Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchyma disorder and/or disease of the liver'}, 'identificationModule': {'nctId': 'NCT01356550', 'briefTitle': 'A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'BP25260'}, 'secondaryIdInfos': [{'id': '2010-023641-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subjects', 'interventionNames': ['Drug: RO4917838']}, {'type': 'EXPERIMENTAL', 'label': 'Hepatic impairment', 'interventionNames': ['Drug: RO4917838']}], 'interventions': [{'name': 'RO4917838', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['Healthy subjects', 'Hepatic impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35042', 'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '117192', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117292', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}