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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00958503

Enrollment

Registered

2009-08-13

Start date

2007-07-31

Completion date

2008-04-30

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

safety, biomarker, thiamphenicol, EAAT2

Brief 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.

Interventions

DRUGThiamphenicol

750 and 1500 mg/day;tablets

DRUGPlacebo

Matched tablets without active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* normal volunteers

Exclusion criteria

* less than 18 years * older than 55 years

Design outcomes

Primary

Measure	Time frame
Amount of EAAT2 RNA in nasal biopsy	Two weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026