Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-01 @ 9:35 PM
Study NCT ID:
NCT00439959
Status:
TERMINATED
Last Update Posted:
2012-06-04
First Post:
2007-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2007-02-22', 'studyFirstSubmitQcDate': '2007-02-22', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety parameters: adverse events; telemetry; clinical laboratory values, vital signs, and ECGs. Plasma levels of GSK625433. Change in HCV viral load. Taken throughout the study', 'timeFrame': '17 Days'}], 'secondaryOutcomes': [{'measure': 'Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study', 'timeFrame': '17 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GSK625433,', 'Hepatitis C,', 'metabolic probe,', 'food-effect,', 'HCV,', 'FTIH', 'polymerase,'], 'conditions': ['Hepatitis C, Chronic', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy males \\& females\n* Part 1 ages 18-60\n* Part 2 ages 18-50 \\& 65-80\n* Within normal weight range given your height\n* Negative urine drug and alcohol test\n* Willing to follow all study procedures\n\nExclusion criteria:\n\n* Any significant abnormal lab, ECG, medical or physical exam finding during screening\n* Allergy to the study drug\n* Excessive alcohol intake\n* Positive HIV or hepatitis B or C result\n* Use of prescription or non-prescription drugs within one week of study start except for birth control\n* Blood pressure meds \\& Tylenol\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00439959', 'briefTitle': 'Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK625433 in Healthy Subjects and in Subjects Who Are Chronically Infected With Hepatitis C.', 'orgStudyIdInfo': {'id': 'HSP108233'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GSK625433/placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}