Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 11:07 PM
Study NCT ID:
NCT00400660
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2006-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First Time In Human Study To Assess The Compound GSK615915
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001986', 'term': 'Bronchial Spasm'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2006-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-27', 'studyFirstSubmitDate': '2006-11-15', 'studyFirstSubmitQcDate': '2006-11-15', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)', 'timeFrame': 'Up to 18 weeks'}], 'secondaryOutcomes': [{'measure': 'Levels of GSK615915A and any breakdown products in the blood and urine.', 'timeFrame': 'Up to 18 weeks'}]}, 'conditionsModule': {'keywords': ['GSK615915 asthma surfactant MDI'], 'conditions': ['Bronchospasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/OLA103920?search=study&study_ids=OLA103920#rs', 'label': 'Results for study OLA103920 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': "GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women of non-child bearing potential.\n* Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m²\n* The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years.\n* The subject has demonstrated the ability to correctly use a metered dose inhaler device.\n* If asthmatic:\n\nThe subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.\n\nExclusion Criteria:\n\n* As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.\n* The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate.\n* The subject has recently participated in another clinical trial.\n* The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 or 14 days.\n* The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.\n* Any history of breathing problems (e.g. history of asthmatic symptoms).\n* The subject is infected with the hepatitis B, hepatitis C, or HIV virus.\n* The subject is has a positive drugs of abuse test.\n* The subject has had a respiratory tract infection within 4 weeks of the start of the study.\n* The subject has a past or present disease, which as judged by the Doctor, may affect the outcome of this study.\n* The subject has a history of life-threatening asthma.\n* The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.\n* The subject has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit.\n* The subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit.\n* The subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation.\n* The subject has ongoing rhinitis that requires treatment.'}, 'identificationModule': {'nctId': 'NCT00400660', 'briefTitle': 'A First Time In Human Study To Assess The Compound GSK615915', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915', 'orgStudyIdInfo': {'id': 'OLA103920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence 1: Part 1', 'description': 'Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.', 'interventionNames': ['Drug: GSK615915A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence 2: Part 1', 'description': 'Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.', 'interventionNames': ['Drug: GSK615915A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence 1: Part 2', 'description': 'Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.', 'interventionNames': ['Drug: GSK615915A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving treatment sequence 2: Part 2', 'description': 'Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.', 'interventionNames': ['Drug: GSK615915A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving GSK615915A: Part 3', 'description': 'Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms.', 'interventionNames': ['Drug: GSK615915A']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects receiving placebo: Part 3', 'description': 'Eligible subjects will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GSK615915A', 'type': 'DRUG', 'description': 'GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.', 'armGroupLabels': ['Subjects receiving GSK615915A: Part 3', 'Subjects receiving treatment sequence 1: Part 1', 'Subjects receiving treatment sequence 1: Part 2', 'Subjects receiving treatment sequence 2: Part 1', 'Subjects receiving treatment sequence 2: Part 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will also receive placebo inhaler.', 'armGroupLabels': ['Subjects receiving placebo: Part 3', 'Subjects receiving treatment sequence 1: Part 1', 'Subjects receiving treatment sequence 1: Part 2', 'Subjects receiving treatment sequence 2: Part 1', 'Subjects receiving treatment sequence 2: Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH14 4AP', 'city': 'Edinburgh', 'state': 'West Lothian', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}