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

This study has been completed.
SGS Life Sciences
Information provided by (Responsible Party):
Richard Chipkin, Psyadon Pharma Identifier:
First received: August 12, 2009
Last updated: March 24, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Healthy Drug: Thiamphenicol Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by Richard Chipkin, Psyadon Pharma:

Primary Outcome Measures:
  • Amount of EAAT2 RNA in nasal biopsy [ Time Frame: Two weeks ]

Enrollment: 30
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Placebo
Matched tablets without active ingredient
Active Comparator: Thiamphenicol
Active comparator
Drug: Thiamphenicol
750 and 1500 mg/day;tablets
Other Name: Thiamphenicol, Urfamycine (trade name in Belgium)

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • normal volunteers

Exclusion Criteria:

  • less than 18 years
  • older than 55 years
  Contacts and Locations
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Please refer to this study by its identifier: NCT00958503

SGS Research Unit - Stuivenberg
Antwerpen, Belgium
Sponsors and Collaborators
Psyadon Pharma
SGS Life Sciences
Principal Investigator: Richard E Chipokin, PhD Ruxton Pharmaceuticals
  More Information

Responsible Party: Richard Chipkin, President and CEO, Psyadon Pharma Identifier: NCT00958503     History of Changes
Other Study ID Numbers: EAAT2 Biomarker
Study First Received: August 12, 2009
Last Updated: March 24, 2015

Keywords provided by Richard Chipkin, Psyadon Pharma:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 21, 2017