Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-01 @ 10:09 AM
Study NCT ID:
NCT00629733
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-07', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-26', 'lastUpdatePostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers', 'timeFrame': 'safety parameters'}], 'secondaryOutcomes': [{'measure': 'Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.', 'timeFrame': 'anti-Xa activity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'ultra low molecular weight heparin'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy volunteers: male subjects aged between 18 and 45 years\n2. Body weight: 65-75 Kg\n3. Not meaningful abnormalities in physical examination and in clinical history\n4. Without evidence of significant organic or psychiatric illness\n5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory\n6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range\n7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months\n8. Not give blood in the last 4 weeks.\n9. Healthy male volunteers who have not received heparin in the past\n10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent\n\nExclusion Criteria:\n\n1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption\n2. Important consumption of exciting drinks: alcohol consumption \\> 30 g/day; coffee, tea, cola \\> 5 /day\n3. Allergy, idiosyncrasy or hypersensitivity to medicines\n4. Healthy volunteers who are receiving another medication in the past 15 days\n5. Positive serology of hepatitis B, C or HIV\n6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events\n7. Mayor Surgery in the last 6 months\n8. Smoking \\> 10 cigarettes / day\n9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine\n10. Healthy volunteers with a familiar history evident hemorrhagic episodes'}, 'identificationModule': {'nctId': 'NCT00629733', 'briefTitle': 'Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rovi Pharmaceuticals Laboratories'}, 'orgStudyIdInfo': {'id': 'ROV-RO14-2006-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ro-14', 'interventionNames': ['Drug: RO-14']}], 'interventions': [{'name': 'RO-14', 'type': 'DRUG', 'armGroupLabels': ['Ro-14']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Dr Manuel Barbanoj', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rovi Pharmaceuticals Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Barbanoj', 'oldOrganization': 'Hospital Santa Creu i Sant Pau'}}}}