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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958503
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : March 25, 2015
SGS Life Sciences
Information provided by (Responsible Party):
Richard Chipkin, Psyadon Pharma

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Thiamphenicol Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : July 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : April 2008

Arm Intervention/treatment
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)

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958503

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

Responsible Party: Richard Chipkin, President and CEO, Psyadon Pharma Identifier: NCT00958503     History of Changes
Other Study ID Numbers: EAAT2 Biomarker
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Richard Chipkin, Psyadon Pharma:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents