Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-27 @ 8:28 PM
Study NCT ID:
NCT00423761
Status:
COMPLETED
Last Update Posted:
2009-05-18
First Post:
2007-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'C552097', 'term': 'GW 876008'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'statusVerifiedDate': '2009-05', 'lastUpdateSubmitDate': '2009-05-15', 'studyFirstSubmitDate': '2007-01-17', 'studyFirstSubmitQcDate': '2007-01-17', 'lastUpdatePostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood levels of GW876008 and midazolam collected on Day 1 of Session 1 and on Days 1 and 14 of Session 2.', 'timeFrame': 'on Day 1 of Session 1 and on Days 1 and 14 of Session 2.'}], 'secondaryOutcomes': [{'measure': '12-lead ECG, Continuous Lead II Telemetry & adverse events: day 1 session 1; days 1 & 14 session 2', 'timeFrame': 'day 1 session 1; days 1 & 14 session 2'}, {'measure': 'vital signs & clinical laboratory data: day 1 session 1; days 1, 7 & 14 session 2', 'timeFrame': 'day 1 session 1; days 1, 7 & 14 session 2'}]}, 'conditionsModule': {'keywords': ['Pharmacokinetics,', 'tolerability,', 'healthy,', 'subjects'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females.\n* Normal ECG.\n* Agree to remain in the clinic for the time defined in the protocol.\n* Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.\n\nExclusion Criteria:\n\n* Any serious medical disorder or condition.\n* Any history of an endocrine disorder.\n* Any clinically significant laboratory abnormality.\n* History of psychiatric illness.\n* Any history of suicidal attempts or behavior.\n* Active peptic ulcer disease.\n* Positive faecal occult blood.\n* The subject smokes or has smoked or has used any nicotine-containing products in the last six months.\n* Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.'}, 'identificationModule': {'nctId': 'NCT00423761', 'briefTitle': 'An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-Label, Single-Sequence Study to Evaluate the Potential CYP 3A4 Pharmacokinetic Interaction of GW876008 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CRH103152'}}, 'armsInterventionsModule': {'interventions': [{'name': 'midazolam', 'type': 'DRUG'}, {'name': 'GW876008', 'type': 'DRUG', 'otherNames': ['midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'GSK Clinical Trials, MBChB, MFPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}