Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT00958503
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2009-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013839', 'term': 'Thiamphenicol'}], 'ancestors': [{'id': 'D002701', 'term': 'Chloramphenicol'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009578', 'term': 'Nitrobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009574', 'term': 'Nitro Compounds'}]}}, '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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2009-08-12', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of EAAT2 RNA in nasal biopsy', 'timeFrame': 'Two weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['safety', 'biomarker', 'thiamphenicol', 'EAAT2'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken from the nasal passages.', 'detailedDescription': 'Thiamphenicol has been proposed to increase the levels of the excitatory amino acid transporter 2 (EAAT2) in the nervous tissue. This study evaluated the ability of two weeks of treatment with thiamphenicol to increase EAAT2 in a nasal biopsy as a surrogate of brain nervous tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal volunteers\n\nExclusion Criteria:\n\n* less than 18 years\n* older than 55 years'}, 'identificationModule': {'nctId': 'NCT00958503', 'briefTitle': 'Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue', 'organization': {'class': 'INDUSTRY', 'fullName': 'Psyadon Pharma'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 14-Day Repeated-Dose Administration of Thiamphenicol (RUX 122) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'EAAT2 Biomarker'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thiamphenicol', 'description': 'Active comparator', 'interventionNames': ['Drug: Thiamphenicol']}], 'interventions': [{'name': 'Thiamphenicol', 'type': 'DRUG', 'otherNames': ['Thiamphenicol, Urfamycine (trade name in Belgium)'], 'description': '750 and 1500 mg/day;tablets', 'armGroupLabels': ['Thiamphenicol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched tablets without active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Research Unit - Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Richard E Chipokin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruxton Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psyadon Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'SGS Life Sciences, a division of SGS Belgium NV', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President and CEO', 'investigatorFullName': 'Richard Chipkin', 'investigatorAffiliation': 'Psyadon Pharma'}}}}