Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 7:17 AM
Study NCT ID:
NCT01147692
Status:
COMPLETED
Last Update Posted:
2017-06-08
First Post:
2010-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug Interaction Study of Simvastatin and Albiglutide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'C534611', 'term': 'rGLP-1 protein'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2010-04-29', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of albiglutide on the pharmacokinetics of simvastatin', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['albiglutide', 'simvastatin', 'healthy volunteers', 'pharmacokinetics'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'availIpds': [{'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '108366', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '25387217', 'type': 'DERIVED', 'citation': 'Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.'}], 'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/108366?search=study&study_ids=108366#rs', 'label': 'Results for study 108366 can be found on the GSK Clinical Study Register.'}, {'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.', 'detailedDescription': 'This Phase I open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no clinically significant diseases or clinically significant abnormal laboratory values\n* females must be of non-childbearing potential\n* body mass index (BMI) is \\>/=18 kg and ≤30 kg/m2\n* nonsmoker\n* negative drug screen\n\nExclusion Criteria:\n\n* positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)\n* any clinically relevant abnormality\n* female subject is pregnant or breast-feeding\n* history of any anaphylactic reaction to any drug\n* history of significant cardiovascular or pulmonary dysfunction\n* current or chronic history of liver disease\n* history of alcohol or substance abuse\n* history of thyroid dysfunction or disease\n* history of gastrointestinal surgery or disease\n* history of pancreatitis\n* previously received any GLP-1 mimetic compound (e.g., exenatide)'}, 'identificationModule': {'nctId': 'NCT01147692', 'briefTitle': 'A Drug Interaction Study of Simvastatin and Albiglutide', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '108366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'simvastatin plus albiglutide', 'description': 'A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.', 'interventionNames': ['Biological: simvastatin plus albiglutide']}], 'interventions': [{'name': 'simvastatin plus albiglutide', 'type': 'BIOLOGICAL', 'description': 'A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.', 'armGroupLabels': ['simvastatin plus albiglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}