Fungal InfectionPhase 1NCT00136968
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy
A Phase 1 study testing Voriconazole in people with Fungal Infection, run by Pfizer.
Trial summary
The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fungal Infection
- What is being tested?
- Voriconazole
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 2005
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers 18-55 years of age
Who cannot join
- Subjects with any condition affecting drug absorption
- Subjects with a positive urine drug screen
About this study
The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.
- Conditions
- Fungal Infection
- Being tested
- Voriconazole
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startApr 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mclean Hospital
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136968
- Sponsor's protocol ID
- A1501060
- Status last verified
- Mar 2009
- First submitted
- 25 Aug 2005
- Last updated
- 12 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT00136968
- Acronym / sponsor ID
- A1501060
- Conditions
- Fungal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Mclean Hospital
- Study start
- Apr 2005
- Study completion
- May 2005 (actual)
- First posted
- 29 Aug 2005 (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 the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers 18-55 years of age
Key exclusion criteria (2 listed)
- Subjects with any condition affecting drug absorption
- Subjects with a positive urine drug screen
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 |
|---|---|---|
| Voriconazole | Drug | – |
Primary outcome
Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS
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 12 Mar 2009.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Voriconazole in people with Fungal Infection, run by Pfizer.
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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS. 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 12 Mar 2009.