Infections, FungalPhase 4NCT00300677

To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days

A Phase 4 study testing voriconazole in people with Infections, Fungal, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma. 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: Infections, Fungal
What is being tested?: voriconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Mar 2007to Aug 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects must be willing and able to provide informed consent.
Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Who cannot join

Subjects with any condition affecting drug absorption.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Belmont, Massachusetts, 02478-1041

Other trials in United States

About this study

Official title: Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy

To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.

Conditions: Infections, Fungal
Being tested: voriconazole
Keywords: Pharmacokinetics, Voriconazole, Magnetic Resonance Spectroscopy
Medical subject headings: Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

voriconazoleDrug
Also called Vfend
Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily

Study groups in NCT00300677
Study group	Role	What they receive
voriconazole	Experimental	voriconazole twice daily Receives: Drug: voriconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Concentrations of Voriconazole
Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.
Measured: Day 3: pre-dose, 2 hours post-dose
Brain Concentrations of Voriconazole
Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).
Measured: Day 3: pre-dose, 2 hours post-dose
Plasma Concentrations of N-oxide Metabolite
Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.
Measured: Day 3: pre-dose, 2 hours post-dose
Brain Concentrations of N-oxide Metabolite
Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).
Measured: Day 3: pre-dose, 2 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Aug 2008

First posted9 Mar 2006 (estimated)
Study startMar 2007
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, FungalStudies 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 4
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00300677
Sponsor's protocol ID: A1501079
Status last verified: Oct 2009
First submitted: 7 Mar 2006
Last updated: 14 Oct 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Henry ME, Bolo NR, Zuo CS, Villafuerte RA, Cayetano K, Glue P, Damle BD, Andrews E, Lauriat TL, Rana NS, Churchill JH, Renshaw PF. Quantification of brain voriconazole levels in healthy adults using fluorine magnetic resonance spectroscopy. Antimicrob Agents Chemother. 2013 Nov;57(11):5271-6. doi: 10.1128/AAC.00394-13. Epub 2013 Aug 12.
PubMed 23939898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infections, Fungal trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 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: NCT00300677
Acronym / sponsor ID: A1501079
Conditions: Infections, Fungal
Keywords: Pharmacokinetics, Voriconazole, Magnetic Resonance Spectroscopy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: McLean Hospital. Belmont, MA.
Study start: Mar 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 9 Mar 2006 (estimated)
Results: Posted 14 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
voriconazole	Experimental	Drug: voriconazolevoriconazole twice daily

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Subjects must be willing and able to provide informed consent.
Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Key exclusion criteria (1 listed)

Subjects with any condition affecting drug absorption.

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
voriconazoleAlso: VfendMultiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily	Drug	voriconazole

Primary outcome

Plasma Concentrations of Voriconazole
Time frame: Day 3: pre-dose, 2 hours post-dose
Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.
Brain Concentrations of Voriconazole
Time frame: Day 3: pre-dose, 2 hours post-dose
Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).
Plasma Concentrations of N-oxide Metabolite
Time frame: Day 3: pre-dose, 2 hours post-dose
Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.
Brain Concentrations of N-oxide Metabolite
Time frame: Day 3: pre-dose, 2 hours post-dose
Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).

Results and safety

Results posted to the registry on 14 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voriconazole	12	12

Primary outcome: Plasma Concentrations of Voriconazole

Time frame: Day 3: pre-dose, 2 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Voriconazole n = 12
predose (Cmin)	839.50 (874.22)
2 hours postdose (C2h)	2182.33 (1190.63)

Voriconazole: predose: ratio adjusted geometric means: 300.28 (90% CI 192.91 to 467.43), ANOVA
Voriconazole: postdose: ratio adjusted geometric means: 192.72 (90% CI 123.81 to 300.00), ANOVA

Population analysed: Pharmacokinetic Analysis Set: subjects included in the statistical analysis of pharmacokinetic parameters had the pharmacokinetic parameter of interest. N=number of observations (non-missing concentrations).

Primary outcome: Brain Concentrations of Voriconazole

Time frame: Day 3: pre-dose, 2 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Voriconazole n = 12
predose (Cmin)	2090.44 (1227.88)
2 hours postdose (C2h)	4165.20 (1806.93)

Voriconazole: predose: ratio adjusted geometric means: 300.28 (90% CI 192.91 to 467.43), ANOVA
Voriconazole: postdose: ratio adjusted geometric means: 192.72 (90% CI 123.81 to 300.00), ANOVA

Primary outcome: Plasma Concentrations of N-oxide Metabolite

Time frame: Day 3: pre-dose, 2 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Voriconazole n = 12
predose (Cmin)	3076.67 (841.96)
2 hours postdose (C2h)	3665.00 (958.73)

Voriconazole: predose: ratio adjusted geometric means: 12.39 (90% CI 7.09 to 21.65), ANOVA
Voriconazole: postdose: ratio adjusted geometric means: 31.57 (90% CI 18.06 to 55.18), ANOVA

Primary outcome: Brain Concentrations of N-oxide Metabolite

Time frame: Day 3: pre-dose, 2 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Voriconazole n = 12
predose (Cmin)	663.97 (677.55)
2 hours postdose (C2h)	1535.40 (1280.09)

Voriconazole: predose: ratio adjusted mean: 12.39 (90% CI 7.09 to 21.65), ANOVA
Voriconazole: postdose: ratio adjusted mean: 31.57 (90% CI 18.06 to 55.18), ANOVA

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voriconazole	0 of 12 (0%)	11 of 12 (91.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23939898Henry ME, Bolo NR, Zuo CS, Villafuerte RA, Cayetano K, Glue P, Damle BD, Andrews E, Lauriat TL, Rana NS, Churchill JH, Renshaw PF. Quantification of brain voriconazole levels in healthy adults using fluorine magnetic resonance spectroscopy. Antimicrob Agents Chemother. 2013 Nov;57(11):5271-6. doi: 10.1128/AAC.00394-13. Epub 2013 Aug 12.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing voriconazole in people with Infections, Fungal, run by Pfizer at 1 site in United States.

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 2 inclusion and 1 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 14 Oct 2009. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plasma Concentrations of Voriconazole (time frame: Day 3: pre-dose, 2 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00300677, which also lists 1 linked publication.

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 14 Oct 2009.