Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT00721812
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2008-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
Sponsor:
Organization:
Raw JSON
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'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2008-07-22', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Safety and tolerability as determined by AE reporting and treatment effects on vital signs, ECG findings, haematology, clinical chemistry and urinalysis parameters, as well as 24-hour plasma cortisol profiles', 'timeFrame': '72 hours and 14 days'}], 'secondaryOutcomes': [{'measure': 'PK parameters per protocol', 'timeFrame': '72 hours and 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'Phase 1', 'first time in humans', 'IBD', 'safety', 'human volunteers'], 'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'availIpds': [{'id': '111406', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111406', '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': '111406', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111406', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111406', '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': '111406', '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': '111406', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'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.'}, {'url': 'https://gsk-clinicalstudyregister.com/study/111406?search=study&study_ids=111406#rs', 'label': 'Results for study 111406 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Healthy as determined by a responsible physician\n* Male, or only for the RDF cohort female of non-childbearing potential, between 18 and 65 years of age.\n* Body weight greater than 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 (inclusive).\n* QTcB or QTcF \\< 450 msec\n* Capable of giving written informed consent\n\nExclusion criteria:\n\n* The subject has a positive pre-study drug/alcohol screen\n* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units\n* Urinary cotinine levels indicative of active smoking or regular use of tobacco\n* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody\n* A positive test for HIV antibody\n* The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives of the investigational product\n* Exposure to more than four new chemical entities within 12 months\n* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days\n* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices within 7 days\n* Subject is receiving hormone replacement therapy\n* History of sensitivity to any of the study medications\n* History of sensitivity to heparin or heparin-induced thrombocytopenia"}, 'identificationModule': {'nctId': 'NCT00721812', 'briefTitle': 'A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers Using a Dose-Escalating, Randomized, Placebo-Controlled Study Design', 'orgStudyIdInfo': {'id': '111406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Part A', 'description': 'Single dose escalation', 'interventionNames': ['Drug: GSK1399686']}, {'type': 'OTHER', 'label': 'Part B', 'description': '14 day repeat dose escalation', 'interventionNames': ['Drug: GSK1399686']}, {'type': 'OTHER', 'label': 'Part C', 'description': 'Fixed dose food effect', 'interventionNames': ['Drug: GSK1399686']}], 'interventions': [{'name': 'GSK1399686', 'type': 'DRUG', 'description': 'Safety and tolerability dose escalation in normal human volunteers', 'armGroupLabels': ['Part A', 'Part B', 'Part C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], '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'}}}}