Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00895102
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2009-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers
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': 'C588260', 'term': 'dasabuvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-10-12', 'studyFirstSubmitDate': '2009-05-07', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation', 'timeFrame': '2 days post dosing'}, {'measure': 'To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo', 'timeFrame': '2 days post dosing'}, {'measure': 'To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation', 'timeFrame': '2 days post dosing'}, {'measure': 'Pharmacokinetics', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability (BA)', 'Single Ascending Dose (SAD)'], 'conditions': ['HCV Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overall healthy subjects;\n* non-childbearing potential females included\n\nExclusion Criteria:\n\n* history of significant sensitivity to any drug;\n* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;\n* history of gastrointestinal issues or procedures;\n* history of seizures, diabetes or cancer (except basal cell carcinoma);\n* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;\n* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;\n* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;\n* abnormal screening laboratory results that are considered clinically significant by the investigator;\n* current enrollment in another clinical study;\n* previous enrollment in this study;\n* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;\n* pregnant or breastfeeding female;\n* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis'}, 'identificationModule': {'nctId': 'NCT00895102', 'briefTitle': 'Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'An Open-Label Randomized, Crossover Study to Evaluate the Bioavailability of ABT-333 Tablets Versus Capsules, and A Double-blind, Randomized, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending Doses of ABT-333 Tablets Versus Placebo in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'M11-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1. ABT-333 Capsule vs ABT-333 Tablet', 'description': '400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose', 'interventionNames': ['Drug: ABT-333 Tablet', 'Drug: ABT-333 Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2. ABT-333 Tablet', 'description': 'ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)', 'interventionNames': ['Drug: ABT-333 Tablet', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3. Placebo', 'description': 'Placebo tablets, QD, single ascending doses', 'interventionNames': ['Drug: ABT-333 Tablet', 'Drug: Placebo']}], 'interventions': [{'name': 'ABT-333 Tablet', 'type': 'DRUG', 'otherNames': ['ABT-333'], 'description': 'See Arm Description for more information.', 'armGroupLabels': ['1. ABT-333 Capsule vs ABT-333 Tablet', '2. ABT-333 Tablet', '3. Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'See Arm Description for more information.', 'armGroupLabels': ['2. ABT-333 Tablet', '3. Placebo']}, {'name': 'ABT-333 Capsule', 'type': 'DRUG', 'description': 'See arm description for more information', 'armGroupLabels': ['1. ABT-333 Capsule vs ABT-333 Tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60085', 'city': 'Waukegan', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 19441', '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'}}}}