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

This study has been completed.
Sponsor:
Collaborator:
SGS Life Sciences
Information provided by (Responsible Party):
Richard Chipkin, Psyadon Pharma
ClinicalTrials.gov Identifier:
NCT00958503
First received: August 12, 2009
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Psyadon Pharma:

Primary Outcome Measures:
  • Amount of EAAT2 RNA in nasal biopsy [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

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
Placebo
Drug: Placebo
Matched tablets without active ingredient
Other Name: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal volunteers

Exclusion Criteria:

  • less than 18 years
  • older than 55 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958503

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

No publications provided

Responsible Party: Richard Chipkin, President and CEO, Psyadon Pharma
ClinicalTrials.gov Identifier: NCT00958503     History of Changes
Other Study ID Numbers: EAAT2 Biomarker
Study First Received: August 12, 2009
Last Updated: March 24, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Psyadon Pharma:
safety
biomarker
thiamphenicol
EAAT2

Additional relevant MeSH terms:
Thiamphenicol
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015