NCT00958503

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Psyadon Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Thiamphenicol	750 and 1500 mg/day;tablets
DRUG	Placebo	Matched tablets without active ingredient

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-09-01
• Completion: 2008-04-01
• First posted: 2009-08-13
• Last updated: 2015-03-25

Locations

1 site across 1 country: Belgium