Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00890318
Status:
COMPLETED
Last Update Posted:
2010-10-21
First Post:
2009-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625346', 'term': 'ABT-072'}, {'id': 'D007654', 'term': 'Ketoconazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-10-19', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of pharmacokinetic results.', 'timeFrame': 'Study Days 1-13'}, {'measure': 'Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.', 'timeFrame': 'Study Days -2 through 39'}], 'secondaryOutcomes': [{'measure': 'Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.', 'timeFrame': 'Study Day 11-13'}]}, 'conditionsModule': {'conditions': ['HCV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.', 'detailedDescription': 'Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Main Selection Criteria for Healthy Volunteers:\n\n * Subject has provided written consent.\n * Subject is in general good health.\n * If female, subject is postmenopausal for at least 2 years or surgically sterile.\n * If female, subject is not pregnant and is not breast-feeding.\n * Male or female between 18 and 55 years old, inclusive.\n * If male, subject must be surgically sterile or practicing at least 1 method of birth control.\n * Body Mass Index (BMI) is 18 to 29, inclusive.\n\nExclusion Criteria:\n\n* Use of medications including over the counter and vitamines.\n* Abuse of alcohol, drugs, or nicotine.\n* Current diseases or disorders.\n* History of cardiac disease.\n* If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.'}, 'identificationModule': {'nctId': 'NCT00890318', 'briefTitle': 'A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'orgStudyIdInfo': {'id': 'M10-705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole', 'interventionNames': ['Drug: ABT-072', 'Other: ketoconazole', 'Drug: Placebo']}, {'type': 'OTHER', 'label': '2', 'description': 'Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.', 'interventionNames': ['Drug: ABT-072', 'Drug: Placebo']}, {'type': 'OTHER', 'label': '3', 'description': 'Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.', 'interventionNames': ['Drug: ABT-072', 'Drug: Placebo']}], 'interventions': [{'name': 'ABT-072', 'type': 'DRUG', 'description': 'Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.', 'armGroupLabels': ['1', '2', '3']}, {'name': 'ketoconazole', 'type': 'OTHER', 'description': 'Tablet, see Arm Description for intervention information.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60085', 'city': 'Waukegan', 'state': 'Illinois', 'country': 'United States', 'facility': 'Abbott Clinical Pharmaceutical Research Unit', 'geoPoint': {'lat': 42.36363, 'lon': -87.84479}}], 'overallOfficials': [{'name': 'Daniel Cohen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Daniel Cohen, MD/Study Medical Director', 'oldOrganization': 'Abbott'}}}}