Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT00959634
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2009-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of ABT-126 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000618299', 'term': 'ABT-126'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-11-02', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)', 'timeFrame': 'One day before dosing through day of last dose and up to 6 days after last dose'}, {'measure': 'ABT-126 levels in blood (plasma)', 'timeFrame': 'First dose through last dose and up to 192 hours after last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects between 18 and 50 years of age\n* If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)\n* If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration\n\nExclusion Criteria:\n\n* Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis\n* History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder\n* Presence of any uncontrolled medical illness'}, 'identificationModule': {'nctId': 'NCT00959634', 'briefTitle': 'Pharmacokinetic Study of ABT-126 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'orgStudyIdInfo': {'id': 'M11-988'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dose 1 BID', 'interventionNames': ['Drug: ABT-126']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dose 2 BID', 'interventionNames': ['Drug: ABT-126']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ABT-126', 'type': 'DRUG', 'description': 'Dose administered twice daily on Study Days 1-10', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose administered twice daily on Study Days 1-10', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 22863', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Robert Lenz, MD, PhD / Project Director', 'oldOrganization': 'Abbott'}}}}