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OpenTrials
Completed

NCT Number: NCT00958503

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Research Unit - Stuivenberg

Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • normal volunteers

Exclusion criteria

  • less than 18 years
  • older than 55 years

Treatment and study plan

Thiamphenicol

Drug

750 and 1500 mg/day;tablets

Other names: Thiamphenicol, Urfamycine (trade name in Belgium)

Placebo

Drug

Matched tablets without active ingredient

Primary outcomes

  1. Amount of EAAT2 RNA in nasal biopsy

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

Psyadon Pharma

Industry

Collaborators

  • SGS Life Sciences, a division of SGS Belgium NV

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Aug 13, 2009
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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