Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue

This study has been completed.
Sponsor:
Collaborator:
SGS Life Sciences
Information provided by:
Psyadon Pharma
ClinicalTrials.gov Identifier:
NCT00958503
First received: August 12, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Thiamphenicol
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Psyadon Pharma:

Enrollment: 30
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Matched tablets without active ingredient
Active Comparator: Thiamphenicol Drug: Thiamphenicol
750 and 1500 mg/day;tablets

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal volunteers

Exclusion Criteria:

  • less than 18 years
  • older than 55 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958503

Locations
Belgium
SGS Research Unit - Stuivenberg
Antwerpen, Belgium
Sponsors and Collaborators
Psyadon Pharma
SGS Life Sciences
  More Information

No publications provided

Responsible Party: Dr. L. Cravens
ClinicalTrials.gov Identifier: NCT00958503     History of Changes
Other Study ID Numbers: EAAT2 Biomarker
Study First Received: August 12, 2009
Last Updated: August 12, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Psyadon Pharma:
safety
biomarker
thiamphenicol
EAAT2

Additional relevant MeSH terms:
Thiamphenicol
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014