Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT00743405
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2008-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568644', 'term': 'GSK 1034702'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2008-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2008-08-27', 'studyFirstSubmitQcDate': '2008-08-27', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.', 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of the Bond-Lader Visual Analogue Scale.', 'timeFrame': '20 weeks'}, {'measure': 'Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.', 'timeFrame': '20 weeks'}, {'measure': 'Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'M1 receptor agonist', 'safety', 'pharmacokinetics', 'GSK1034702'], 'conditions': ['Cognitive Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/110623?search=study&search_terms=110623#rs', 'label': 'Results for study 110623 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.\n* Male or female between 18 and 55 years of age.\n* A female subject is eligible to participate if she is of non-childbearing potential\n* Body weight \\> 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).\n* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n* Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.\n* Demonstrates no evidence of mental impairment.\n* No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview\n\nExclusion Criteria:\n\n* A positive pre-study drug/alcohol screen.\n* A positive pre-study Hepatitis B , Hepatitis C or HIV.\n* History of regular alcohol consumption.\n* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .\n* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.\n* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.\n* Pregnant females, females planning pregnancy or 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* Subjects with a current or a history of psychiatric illness.\n* Subjects with any history of suicidal attempts or behavior.\n* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.\n* Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT00743405', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Single-blind, Randomised, Placebo Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects', 'orgStudyIdInfo': {'id': '110623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort 1', 'description': 'Subjects will be receive GSK1034702 0.5 milligram (mg) following the dose escalation plan', 'interventionNames': ['Drug: GSK1034702', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Cohort 2', 'description': 'Subjects will be receive GSK1034702 5 mg following the dose escalation plan', 'interventionNames': ['Drug: GSK1034702', 'Drug: Placebo']}], 'interventions': [{'name': 'GSK1034702', 'type': 'DRUG', 'description': 'Oral or liquid', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'To match GSK1034702', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7NS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}