Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-04 @ 4:31 PM
Study NCT ID:
NCT00792493
Status:
COMPLETED
Last Update Posted:
2009-09-24
First Post:
2008-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588919', 'term': 'ORM-12741'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-23', 'studyFirstSubmitDate': '2008-11-17', 'studyFirstSubmitQcDate': '2008-11-17', 'lastUpdatePostDateStruct': {'date': '2009-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values', 'timeFrame': 'about a month'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '12 days per period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy volunteer study'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good general health ascertained by detailed medical history and physical examinations\n* Males between 18 and 45 years\n* Body mass index (BMI) between 18-30 kg/m2\n* Weight 55-90 kg\n\nExclusion Criteria:\n\n* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease\n* Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study\n* Susceptibility to severe allergic reactions\n* Regular consumption of more than 14 units of alcohol per week\n* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day\n* Inability to refrain from using nicotine-containing products during the stay in the study centre\n* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre\n* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit\n* Abnormal finding in ECG, vital signs, laboratory tests or physical examination\n* Participation in a drug study within 3 months prior to the start of this study'}, 'identificationModule': {'nctId': 'NCT00792493', 'briefTitle': 'Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741', 'orgStudyIdInfo': {'id': '3098002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ORM-12741', 'interventionNames': ['Drug: ORM-12741']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: ORM-12741']}], 'interventions': [{'name': 'ORM-12741', 'type': 'DRUG', 'description': 'Alternating panel multiple dose escalation', 'armGroupLabels': ['ORM-12741', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouffach', 'country': 'France', 'facility': 'Forenap Pharma', 'geoPoint': {'lat': 47.95786, 'lon': 7.30016}}], 'overallOfficials': [{'name': 'Déborah Metzger, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Forenap Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jutta Hänninen, Clinical Study Manager', 'oldOrganization': 'Orion Corporation, Orion Pharma'}}}}