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NCT00958503 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00958503
Other study ID # EAAT2 Biomarker
Secondary ID
Status Completed
Phase Phase 1
First received August 12, 2009
Last updated March 24, 2015
Start date July 2007
Est. completion date April 2008

Study information
Verified date March 2015
Source Psyadon Pharma
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2008
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- normal volunteers

Exclusion Criteria:

- less than 18 years

- older than 55 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Thiamphenicol
750 and 1500 mg/day;tablets
• Placebo
Matched tablets without active ingredient

Locations
Country Name City State
Belgium SGS Research Unit - Stuivenberg Antwerpen

Sponsors (2)
Lead Sponsor Collaborator
Psyadon Pharma SGS Life Sciences

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of EAAT2 RNA in nasal biopsy Two weeks No
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