Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-04 @ 5:30 AM
Study NCT ID:
NCT00692250
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2008-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069472', 'term': 'Colesevelam Hydrochloride'}], 'ancestors': [{'id': 'D000499', 'term': 'Allylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000498', 'term': 'Allyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max))', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '12'}, {'measure': 'Tolerability', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Familial Hypercholesterolemia'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have a body mass index (BMI) between 19 and 25 inclusive\n* Medically healthy subjects with clinically normal laboratory profiles, physical exams, vital signs and ECGs.\n* Give voluntary written informed consent to participate in the study\n\nExclusion Criteria:\n\n* History or presence of significant cardiovascular, pulmonary, hepatic renal, hematologic, gastrointestinal (inclusive of dysphagia, swallowing disorders, severe gastrointestinal motility disorders), endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease.\n* In addition, history or presence of: Alcoholism or drug abuse within the past year; OR hypersensitivity or idiosyncratic reaction to ciclosporin or other immunosuppressive agents; OR Chronic infection\n* Subjects who ere tested positive at screening for HIV, HBsAg or HCV\n* Subjects who received injectable corticosteroids in the 12 weeks preceding the first dose.\n* Subjects who are allergic to castor oil or corn oil\n* Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg before dosing\n* Subjects who have used any medications or substances known to be strong inhibitors of CYP3A enzymes within 10 days prior to the first dose.\n* Subjects who have used any medications or substances known to be strong inducers of CYP3A enzymes within 28 days prior to the first dose.\n* Subjects who have used antibiotics within 14 days prior to the first dose.\n* Subjects who have used other medication (including over-the-counter products) vitamins and herbal products within 7 days prior to the first dose.\n* Subjects who have used any live attenuated vaccine within 7 days prior to the first dose or are planning to use within 14 days after the end of the study.\n* Subjects who, prior to informed consent, would have donated in excess of: 500mL of blood in 14 days;1500mL of blood in 180 days; OR 2500mL of blood in 1 year.\n* Subjects who have participated in another clinical trial: within a period less or equal to 2 half live (t1/2) of the previous investigational product used OR within 60 days prior to first dose.'}, 'identificationModule': {'nctId': 'NCT00692250', 'briefTitle': 'A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase I Open Label, Randomised, Single Dose, 2-way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CHOL00207'}, 'secondaryIdInfos': [{'id': 'EudraCT 2007-003724-38'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Colesevelam hydrochloride film-coated tablets (Cholestagel)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen- Biotech Center', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Corporation'}}}}