NCT00958503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2007

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

August 12, 2009

Last Update Submit

March 24, 2015

Conditions

Healthy

Keywords

safetybiomarkerthiamphenicolEAAT2

Outcome Measures

Primary Outcomes (1)

  • Amount of EAAT2 RNA in nasal biopsy

    Two weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Thiamphenicol

ACTIVE COMPARATOR

Active comparator

Drug: Thiamphenicol

Interventions

ThiamphenicolDRUG

750 and 1500 mg/day;tablets

Also known as: Thiamphenicol, Urfamycine (trade name in Belgium)
Thiamphenicol
PlaceboDRUG

Matched tablets without active ingredient

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal volunteers

You may not qualify if:

  • less than 18 years
  • older than 55 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Research Unit - Stuivenberg

Antwerp, Belgium

Location

MeSH Terms

Interventions

Thiamphenicol

Intervention Hierarchy (Ancestors)

ChloramphenicolPropylene GlycolsGlycolsAlcoholsOrganic ChemicalsNitrobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNitro Compounds

Study Officials

  • Richard E Chipokin, PhD

    Ruxton Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President and CEO

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

July 1, 2007

Primary Completion

September 1, 2007

Study Completion

April 1, 2008

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

BE(1)