Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-01 @ 10:54 AM
Study NCT ID:
NCT01145768
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2010-06-07', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs", 'timeFrame': 'Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events.'}], 'secondaryOutcomes': [{'measure': 'To characterize the pharmacokinetics of TC-5214 in blood and urine after single and repeated oral doses by collecting blood and urine samples to measure drug concentration levels', 'timeFrame': 'Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11.'}, {'measure': 'To assess the effect of food on the pharmacokinetics of TC-5214 following oral administration by collecting blood and urine samples to measure drug concentration levels.', 'timeFrame': 'Samples taken during the residential period at defined timepoints pre-dose and post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Double-blind', 'randomized', 'placebo-controlled', 'parallel-group study', 'Safety', 'pharmacokinetics'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '24408516', 'type': 'DERIVED', 'citation': 'Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and nonpregnant, nonlactating female, with suitable veins for cannulation or repeated venipuncture\n* Contraceptive use from the first dose of investigational product until12 weeks after their last dose\n* Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg\n\nExclusion Criteria:\n\n* History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results of\n* History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or unintentional rapid weight loss\n* Volunteers with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study'}, 'identificationModule': {'nctId': 'NCT01145768', 'briefTitle': 'To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1, Single Center, Double-blind, Randomized, Placebo- Controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TC-5214 (S-Mecamylamine) After Administration of Single and Multiple Ascending Doses for up to 8 Days in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'D4130C00006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Each cohort will have 9 volunteers that will receive TC-5214', 'interventionNames': ['Drug: TC-5214']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Each cohort will have 3 volunteers that will receive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TC-5214', 'type': 'DRUG', 'description': '4 mg tablet, oral, BID, group 1', 'armGroupLabels': ['1']}, {'name': 'TC-5214', 'type': 'DRUG', 'description': 'TBD tablet, oral, BID, groups 2-6', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'David Mathews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles, Inc.'}, {'name': 'Donna Holloway', 'role': 'STUDY_CHAIR', 'affiliation': 'Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}}