Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01392820
Status:
COMPLETED
Last Update Posted:
2011-11-15
First Post:
2011-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-14', 'studyFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2011-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS.', 'timeFrame': 'During the whole study period, ca. 50 days'}], 'secondaryOutcomes': [{'measure': 'characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers.', 'timeFrame': 'PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I', 'Japan', 'Elderly', 'PK', 'SAD', 'MAD'], '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': 'The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese healthy elderly male and female ≥65 years old.\n* Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.\n* Be able to understand and comply with the requirements of the study as judged by the investigator(s).\n\nExclusion Criteria:\n\n* History of any clinically significant medical or neurologic disease or disorder.\n* History of gastrointestinal surgery or unintentional rapid weight loss.\n* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.'}, 'identificationModule': {'nctId': 'NCT01392820', 'briefTitle': 'A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers', 'orgStudyIdInfo': {'id': 'D4131C00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TC-5214', 'interventionNames': ['Drug: TC-5214']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TC-5214', 'type': 'DRUG', 'description': 'Tablet, Oral, twice daily', 'armGroupLabels': ['TC-5214']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet, Oral, twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Hans Eriksson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Shunji Matsuki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyushu Clinical Pharmacology Research Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}