Trial | NCT00958503  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rifampin ...

  • Study Participants

    30
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.
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.
Study Started
Jul 31
2007
Primary Completion
Sep 30
2007
Study Completion
Apr 30
2008
Last Update
Mar 25
2015
Estimate

Drug Thiamphenicol

750 and 1500 mg/day;tablets

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

Drug Placebo

Matched tablets without active ingredient

Placebo Placebo Comparator

Placebo

Thiamphenicol Active Comparator

Active comparator

Criteria 

Inclusion Criteria:

normal volunteers

Exclusion Criteria:

less than 18 years
older than 55 years
No Results Posted