Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 8:11 AM
Study NCT ID:
NCT00731250
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512301', 'term': 'SB 705498'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2009-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-11', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom scores and secretion weights', 'timeFrame': 'up to 83 days'}], 'secondaryOutcomes': [{'measure': 'Peak nasal inspiratory flow changes after challenge', 'timeFrame': 'up to 83 days'}, {'measure': 'Biomarkers levels in the nasal samples', 'timeFrame': 'up to 83 days'}, {'measure': 'Blood levels of drug', 'timeFrame': 'up to 83 days'}, {'measure': 'Pharmacodynamic response', 'timeFrame': 'up to 83 days'}, {'measure': 'Safety parameters', 'timeFrame': 'up to 83 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Capsaicin challenge'], 'conditions': ['Rhinitis']}, 'referencesModule': {'availIpds': [{'id': '111611', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111611', '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': '111611', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '111611', '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': '111611', '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': '111611', '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': '111611', '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.gsk-clinicalstudyregister.com/study/111611?search=study&search_terms=111611#rs', 'label': 'Results for study 111611 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 study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy.\n* Male or female between 18 and 60 years of age inclusive.\n* Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol\n* Non-smoker for at least 6 months with a pack history \\<5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).\n* Body weight \\> 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2 (inclusive).\n* Capable of giving written informed consent.\n* Available to complete all the required study measurements.\n* Normal 12-lead ECG at screening.\n* For Part 2 only: The subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.\n\nExclusion Criteria:\n\n* Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis.\n* Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.\n* A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.\n* Positive pre-study drug/alcohol screen.\n* Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.\n* A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).\n* History of regular alcohol consumption within 6 months of the study.\n* Exposure to more than four new chemical entities within 12 months prior to the start of the study.\n* Participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months of the start of the study.\n* Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.\n* Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids\n* History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.\n* Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.\n* Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this study.\n* Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.\n* Lactating females.\n* Unwillingness or inability to follow the procedures outlined in the protocol.\n* History of sensitivity to heparin or heparin-induced thrombocytopenia.\n* Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.\n* For Part 2 only: Subjects with known lactose intolerance."}, 'identificationModule': {'nctId': 'NCT00731250', 'briefTitle': 'A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Oral, Single Dose SB-705498 in a Validated Intranasal Capsaicin Challenge Model in Healthy Volunteers', 'orgStudyIdInfo': {'id': '111611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PART 1-Visit 1-Placebo', 'description': 'Eligible subjects will receive matching placebo tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PART 1-Visit 1-Capsaicin', 'description': 'Eligible subjects will receive incremental capsaicin doses', 'interventionNames': ['Other: Caspaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PART 1-Visit 2-Placebo', 'description': 'Eligible subjects will receive matching placebo tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PART 1-Visit 2-Capsaicin', 'description': 'Eligible subjects will receive maximum capsaicin dose', 'interventionNames': ['Other: Caspaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PART 1-Visit 3-Placebo', 'description': 'Eligible subjects will receive matching placebo tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PART 1-Visit 3-Capsaicin', 'description': 'Eligible subjects will receive matching placebo tablets incremental capsaicin doses', 'interventionNames': ['Other: Caspaicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PART 2-Visit 1-Placebo', 'description': 'Eligible subjects will receive matching placebo tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PART 2-Visit 1-SB-705498', 'description': 'Eligible subjects will receive SB-705498 tablets', 'interventionNames': ['Drug: SB-705498']}, {'type': 'EXPERIMENTAL', 'label': 'PART 2-Visit 2-Capsaicin', 'description': 'Eligible subjects will receive matching placebo tablets incremental capsaicin doses', 'interventionNames': ['Other: Caspaicin']}], 'interventions': [{'name': 'SB-705498', 'type': 'DRUG', 'description': 'Subjects will be administered a single dose of 400 mg SB-705498', 'armGroupLabels': ['PART 2-Visit 1-SB-705498']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will be administered SB-705498 matching placebo tablets', 'armGroupLabels': ['PART 1-Visit 1-Placebo', 'PART 1-Visit 2-Placebo', 'PART 1-Visit 3-Placebo', 'PART 2-Visit 1-Placebo']}, {'name': 'Caspaicin', 'type': 'OTHER', 'description': 'Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose', 'armGroupLabels': ['PART 1-Visit 1-Capsaicin', 'PART 1-Visit 2-Capsaicin', 'PART 1-Visit 3-Capsaicin', 'PART 2-Visit 2-Capsaicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], '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'}}}}