HealthyPhase 1NCT00958503
Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue
A Phase 1 study testing Thiamphenicol in people with Healthy, run by Psyadon Pharma at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Thiamphenicol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal volunteers
Who cannot join
- less than 18 years
- older than 55 years
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Thiamphenicol, Placebo
- Keywords
- safety, biomarker, thiamphenicol, EAAT2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamphenicolDrug
Also called Thiamphenicol, Urfamycine (trade name in Belgium)
750 and 1500 mg/day;tablets
PlaceboDrug
Matched tablets without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Thiamphenicol | Active comparator | Active comparator Receives: Drug: Thiamphenicol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of EAAT2 RNA in nasal biopsy
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJul 2007
- Primary completionSep 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psyadon Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Responsible party
- Principal investigator, Richard Chipkin, Psyadon Pharma
- Investigators
- Richard E Chipokin, PhD, Principal investigator, Ruxton Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958503
- Sponsor's protocol ID
- EAAT2 Biomarker
- Status last verified
- Mar 2015
- First submitted
- 12 Aug 2009
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00958503
- Acronym / sponsor ID
- EAAT2 Biomarker
- Conditions
- Healthy
- Keywords
- safety, biomarker, thiamphenicol, EAAT2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Psyadon PharmaIndustry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Study start
- Jul 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Thiamphenicol | Active comparator | Drug: ThiamphenicolActive comparator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- normal volunteers
Key exclusion criteria (2 listed)
- less than 18 years
- older than 55 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamphenicolAlso: Thiamphenicol, Urfamycine (trade name in Belgium)750 and 1500 mg/day;tablets | Drug | Thiamphenicol |
| PlaceboMatched tablets without active ingredient | Drug | Placebo |
Primary outcome
Amount of EAAT2 RNA in nasal biopsy
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Chipokin, PhD principal investigator
Ruxton Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thiamphenicol in people with Healthy, run by Psyadon Pharma at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of EAAT2 RNA in nasal biopsy (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.