Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01053520
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2009-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C528561', 'term': 'navitoclax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2009-11-23', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A .', 'timeFrame': 'Each formulation assessed via 13 PK timepoints over 4 days'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measures include adverse event monitoring, vital signs, physical examinations, ECGs, and laboratory assessments including pharmacogenetics.', 'timeFrame': 'Assessed over the confinement period of 17 days of study duration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Female Subjects']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, open-label, single center, three period crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 12 healthy female subjects will be enrolled in this study.', 'detailedDescription': 'This is a Phase 1, randomized, open-label, single center, three period crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 12 healthy female subjects will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and age is between 18 and 55 years, inclusive.\n* Must be surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), postmenopausal (for at least 2 years), or practicing at least one acceptable method of birth control.\n* Must have negative results for pregnancy tests performed at Screening on a urine sample obtained within 28 days prior to initial study drug administration, and on Period 1 Day -1 on a serum specimen.\n* Body Mass Index (BMI) is 18 to 29, inclusive. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* Must have adequate bone marrow function per local laboratory reference range (Platelets \\>/= lower limit of normal range, ANC \\>/= lower limit of normal range)\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).\n* Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study-specific procedures.\n\nExclusion Criteria:\n\n* History of significant sensitivity to any drug\n* History of drug or alcohol abuse w/i 6 months or currently receiving Disulfiram\n* Known/suspected history of HIV\n* History of or active medical condition(s) or surgical procedure(s) that might affect GI motility, pH, absorption\n* History of thrombocytopenic associated bleeding w/i 1 year prior to ABT-263\n* Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, respiratory (except mild asthma), gastrointestinal, hematologic, or hepatic disease or diabetes, cancer, epilepsy, or seizures that in the opinion of the PI would adversely affect her participating in the study.\n* Underlying condition predisposing to bleeding or currently exhibits signs of clinically significant bleeding or active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.\n* Positive result for drugs of abuse, alcohol, cotinine, hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).\n* Consumed alcohol, grapefruit or starfruit product, or Seville oranges w/i 3 days prior to ABT-263\n* Received aspirin, anticoagulation therapy, or any drugs or herbal supplements that affect platelet function w/i 7 days prior to/during ABT-263\n* Used any medications, vitamins, or herbal supplements (except contraceptives) w/i 14 days prior to ABT-263\n* Received any drug by injection or biologic agent w/i 30 days prior to ABT-263 (except parenteral hormonal contraceptives)\n* Used known inhibitors or inducers CYP3A w/i 1 month prior to ABT-263; Received any investigational product w/i 6 weeks prior to ABT-263\n* Used tobacco or nicotine-products w/i 6 months prior to ABT-263\n* Pregnant or breastfeeding\n* Donation or loss of \\>/=550 mL blood or received transfusion of blood product w/i 8 weeks prior ABT-263\n* Currently enrolled in another study.\n* The PI decides the subject is unsuitable to receive ABT-263.'}, 'identificationModule': {'nctId': 'NCT01053520', 'briefTitle': 'Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'orgStudyIdInfo': {'id': 'M11-957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence I', 'interventionNames': ['Drug: ABT-263']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence II', 'interventionNames': ['Drug: ABT-263']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence III', 'interventionNames': ['Drug: ABT-263']}], 'interventions': [{'name': 'ABT-263', 'type': 'DRUG', 'description': 'Period 1: Single (oral) dose of 25 mg of Formulation A Period 2: Single (oral) dose of 25 mg of Formulation B1 Period 3: Single (oral) dose of 25 mg of Formulation B2', 'armGroupLabels': ['Sequence I']}, {'name': 'ABT-263', 'type': 'DRUG', 'description': 'Period 1: Single (oral) dose of 25 mg of Formulation B1 Period 2: Single (oral) dose of 25 mg of Formulation B2 Period 3: Single (oral) dose of 25 mg of Formulation A', 'armGroupLabels': ['Sequence II']}, {'name': 'ABT-263', 'type': 'DRUG', 'description': 'Period 1: Single (oral) dose of 25 mg of Formulation B2 Period 2: Single (oral) dose of 25 mg of Formulation A Period 3: Single (oral) dose of 25 mg of Formulation B1', 'armGroupLabels': ['Sequence III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60085', 'city': 'Waukegan', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 23602', 'geoPoint': {'lat': 42.36363, 'lon': -87.84479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Andrew Krivoshik, MD, PhD, Medical Director', 'oldOrganization': 'Abbott'}}}}