Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT01702467
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2012-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615596', 'term': 'GSK2647544'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of GSK2647544 as assessed by number of subjects with adverse events (AE)s', 'timeFrame': '5 days in each of the 4 dosing session', 'description': 'Safety and tolerability parameters will include recording of AEs'}, {'measure': 'Safety and tolerability of GSK2647544 as assessed by change from Baseline in laboratory values', 'timeFrame': '5 days in each of the 4 dosing session', 'description': 'Safety and tolerability parameters will include laboratory (haematology, clinical chemistry, urinalysis) values at Screening, Day -1, Day 3 and Follow-up (7-14 days post-last dose)'}, {'measure': 'Safety and tolerability of GSK2647544 as assessed by change from Baseline in ECG readings', 'timeFrame': '5 days in each of the 4 dosing session', 'description': 'Safety and tolerability parameter will include the electrocardiogram (ECG) readings at Screening, Day -1, Day 1, Day 2, Day 3 and Follow-up (7-14 days post-last dose)'}, {'measure': 'Safety and tolerability of GSK2647544 as assessed by change from Baseline in Telemetry ECG parameters', 'timeFrame': '3 Days in each of the 4 dosing session', 'description': 'Safety and tolerability parameter will include the Telemetry ECG readings from 30 minutes pre-dosing till 48 hours post-dosing'}, {'measure': 'Safety and tolerability of GSK2647544 as assessed by change from Baseline in vital signs', 'timeFrame': '5 days in each of the 4 dosing session', 'description': 'Vital signs measurement include systolic and diastolic blood pressure and pulse rate at Screening, Day -1, Day 1, Day 2, Day 3, Day 4 and Follow-up (7-14 days post-last dose)'}, {'measure': 'Safety and tolerability of GSK2647544 as assessed by using the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': '5 days in each of the 4 dosing session', 'description': 'C-SSRS will be measured at Screening, Day -1, Day 1 (conducted prior to discharge) and Follow-up (7-14 days post-last dose)'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax) of GSK2647544', 'timeFrame': '4 Days in each of the 4 dosing session', 'description': 'To assess PK profile of GSK2647544, Cmax of GSK2647544 will be measured'}, {'measure': 'Time of peak plasma concentration (tmax) of GSK2647544', 'timeFrame': '4 Days in each of the 4 dosing session', 'description': 'To assess PK profile of GSK2647544 tmax of GSK2647544 will be measured'}, {'measure': 'Area under the time concentration curve (AUC) of GSK2647544', 'timeFrame': '4 Days in each of the 4 dosing session', 'description': 'To assess PK profile of GSK2647544 AUC of GSK2647544 will be measured'}, {'measure': 'Terminal half-life (t½ ) of GSK2647544', 'timeFrame': '4 Days in each of the 4 dosing session', 'description': 'To assess PK profile of GSK2647544 t½ of GSK2647544 will be measured'}, {'measure': 'Apparent oral clearance (CL/F) of GSK2647544', 'timeFrame': '4 Days in each of the 4 dosing session', 'description': 'To assess PK profile of GSK2647544 CL/F of GSK2647544 will be measured'}, {'measure': 'Predose plasma lipoprotein-associated phospholipase A2 (Lp-PLA2) activity and postdose Lp-PLA2 activity', 'timeFrame': '5 Days in each of the 4 dosing session', 'description': 'It will be measured at Day 1, Day 2, Day 3, Day 4 and Day 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lp-PLA2', "Alzheimer's disease"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'availIpds': [{'id': '116698', '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': '116698', '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': '116698', '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': '116698', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '116698', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '116698', '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': '116698', '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://gsk-clinicalstudyregister.com/study/116698?search=study&search_terms=116698#rs', 'label': 'Results for study 116698 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose design in 2 independent cohorts, eight healthy male subjects in each of the cohorts. Each potential subject will undergo Screening visit, Treatment Phase and Follow-up visit.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males who are 18 to 55 years of age, inclusive\n* Healthy as determined by a responsible and experienced physician\n* aspartate aminotransferase (AST), Alanine transaminase (ALT), alkaline phosphatase and bilirubin \\<= 1.5xUpper Limit of Normal (ULN)\n* Average of triplicate QTcB values and average of triplicate QTcF values must both \\< 450 millisecond (msec)\n* Body weight \\> 50 kg (110 pounds) and body mass index (BMI) between 19 and 30\n* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods\n* Capable of giving written informed consent\n\nExclusion Criteria:\n\n* Those with Lp-PLA2 activity \\<=20 nanomole/minute/milliliter (mL)(for subjects with 2 known birth parents of at least 50% Japanese, Chinese, or Korean ancestry)\n* History of asthma, anaphylaxis or anaphalactoid reactions, severe allergic responses\n* History of hypercoagulable state or history of thrombosis\n* A history of biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology\n* Positive Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C at screening\n* History of regular use of tobacco- or nicotine-containing products within three months of the study and/or has a positive breath CO at screening\n* History of alcohol consumption exceeding, on average, 21 drinks/week for men (1 drink = 100 mL of wine or 240 mL of beer or 30 mL of hard liquor in Australia) within 6 months of the first dose of study medication\n* Positive urine drug or positive breath alcohol test at screening or at admission to Clinical Research Unit\n* Unable to refrain from use of prescription or non-prescription drugs and vitamins within 7 days or 5 half-lives (whichever is longer) prior to administration of study\n* Unable to refrain from use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng and red yeast rice within 14 days prior to treatment with study medication\n* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing\n* Unable to refrain from consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication\n* For male subjects, an unwillingness to abstain from sexual intercourse with pregnant or lactating women or an unwillingness to use a condom plus partner use of a highly effective contraceptive if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study\n* Donation of blood in excess of 500 mL within 56 days prior to dosing\n* History of sensitivity to heparin or heparin-induced thrombocytopenia\n* Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months"}, 'identificationModule': {'nctId': 'NCT01702467', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Single-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers', 'orgStudyIdInfo': {'id': '116698'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK2647544', 'description': 'The starting dose of GSK2647544 is 0.5 mg. The escalating doses to be administered will be determined based on study results from previous dose (s).', 'interventionNames': ['Drug: GSK2647544']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GSK2647544', 'type': 'DRUG', 'description': 'Capsules containing 0.5mg to 50mg of GSK2647544.', 'armGroupLabels': ['GSK2647544']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}], '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'}}}}