Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-13 @ 3:22 PM
Study NCT ID:
NCT00802035
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2008-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-22', 'studyFirstSubmitDate': '2008-11-26', 'studyFirstSubmitQcDate': '2008-12-03', 'lastUpdatePostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to Cmax', 'timeFrame': '5 weeks'}, {'measure': 'Significant abnormal laboratory findings', 'timeFrame': '5 weeks'}, {'measure': 'Area under the plasma concentration curve (AUC)', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ALK29', 'Alcohol Dependence', 'Pharmacokinetics'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 65 years\n* Body mass index of 19 to 30 kg/m2 at screening\n* If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Pregnancy and/or currently breastfeeding\n* Clinical significant medical condition or observed abnormalities\n* Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery\n* Participation in a clinical trial within 30 days before screening\n* Known intolerance and/or hypersensitivity to baclofen or its excipients\n* Use of alcohol-, caffeine-, or xanthine-containing products\n* Clinically significant illness within 30 days of first study drug administration\n* Dietary restrictions that conflict with required study meals'}, 'identificationModule': {'nctId': 'NCT00802035', 'briefTitle': 'ALK29-002: A Study of Baclofen Formulations in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults', 'orgStudyIdInfo': {'id': 'ALK29-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IR am', 'description': '30 mg, single dose, morning administration (immediate release \\[IR\\])', 'interventionNames': ['Drug: Baclofen IR']}, {'type': 'EXPERIMENTAL', 'label': 'ER am', 'description': '30 mg; single dose; morning administration (extended release \\[ER\\])', 'interventionNames': ['Drug: Baclofen ER']}, {'type': 'EXPERIMENTAL', 'label': 'ER pm', 'description': '30 mg; single dose; evening administration', 'interventionNames': ['Drug: Baclofen ER']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IR pm', 'description': '30 mg; single dose; evening administration', 'interventionNames': ['Drug: Baclofen IR']}], 'interventions': [{'name': 'Baclofen IR', 'type': 'DRUG', 'description': '30 mg; single dose', 'armGroupLabels': ['IR am', 'IR pm']}, {'name': 'Baclofen ER', 'type': 'DRUG', 'description': '30 mg; single dose', 'armGroupLabels': ['ER am', 'ER pm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'CEDRA Clinical Research, LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Frederick A. Bieberdorf, MD, CPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEDRA Clinical Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}