Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT01043458
Status:
COMPLETED
Last Update Posted:
2010-11-02
First Post:
2009-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Duration of study'}, {'measure': 'ABT-126 levels in blood (plasma)', 'timeFrame': 'Pre-dose to 144 hours post-dose'}, {'measure': 'Clinical laboratory tests, vital signs and electrocardiogram (ECG)', 'timeFrame': 'Pre-dose to 72 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has signed informed consent;\n* Current diagnosis of schizophrenia;\n* Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;\n* Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);\n* Females are not pregnant, not breast-feeding;\n* Females are post-menopausal or surgically sterile or practicing birth control;\n* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control\n\nExclusion Criteria:\n\n* Diagnosis of schizoaffective disorder;\n* Diagnosis with mental retardation;\n* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;\n* Acute psychosis hospitalization within past 6 months;\n* Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;\n* Current clozapine treatment;\n* Suicidal ideation or behavior;\n* BMI of 39 or greater;\n* Relevant drug sensitivity or allergy;\n* Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;\n* Recent clinically significant illness/infection or surgery;\n* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;'}, 'identificationModule': {'nctId': 'NCT01043458', 'briefTitle': 'Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia', 'orgStudyIdInfo': {'id': 'M11-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ABT-126 Low Dose', 'interventionNames': ['Drug: ABT-126']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'ABT-126 High Dose', 'interventionNames': ['Drug: ABT-126']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Placebo for ABT-126', 'interventionNames': ['Drug: Placebo for ABT-126']}], 'interventions': [{'name': 'ABT-126', 'type': 'DRUG', 'description': 'ABT-126 Low Dose \\& ABT-126 High Dose', 'armGroupLabels': ['1', '2']}, {'name': 'Placebo for ABT-126', 'type': 'DRUG', 'description': 'Matching Placebo for Arms 1 \\& 2', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 25423', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 24322', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Hana Florian, MD / Associate Medical Director', 'oldOrganization': 'Abbott'}}}}