A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents

A Phase 2 study testing Voriconazole in people with Pharmacokinetics, run by Pfizer at 9 sites in United States.

Completed

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

Trial summary

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Pharmacokinetics
What is being tested?: Voriconazole
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 9 sitesUnited States
Study dates: Jun 2008to Dec 2009
Phase: Phase 2
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subjects who are expected to develop neutropenia following chemotherapy.
Subjects who require treatment for the prevention of systemic fungal infection.

Who cannot join

Subjects with a history of severe intolerance of azole antifungal agents.
Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Durham, North Carolina, 27705
Pfizer Investigational Site
Fort Worth, Texas, 76104-2796
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Nashville, Tennessee, 37232-2195
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New Orleans, Louisiana, 70118
Pfizer Investigational Site
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Adolescents Aged 12 To <17 Years Who Are At High Risk For Systemic Fungal Infection

Conditions: Pharmacokinetics
Being tested: Voriconazole
Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents

What participants receive

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

VoriconazoleDrug
Also called Vfend
Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.

Study groups in NCT00556998
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Voriconazole

What is being measured

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

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Measured: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Measured: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Time to Reach Cmax (Tmax) Following IV Administration
Measured: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
AUC12,ss Following Oral Administration
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Measured: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Cmax,ss Following Oral Administration
Measured: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Tmax Following Oral Administration
Measured: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose

Secondary outcomes (10)

AUC12 Following IV Loading Dose
AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.
Measured: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Tmax Following an IV Loading Dose
Measured: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Cmax Following an IV Loading Dose
Measured: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Minimum Observed Plasma Trough Concentration (Cmin)
Measured: Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Measured: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Measured: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Measured: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Measured: On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Measured: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Measured: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

Timeline

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

Jun 2008Dec 2009

First posted12 Nov 2007 (estimated)
Study startJun 2008
Primary completionDec 2009
Study completionDec 2009

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.
Other trials for PharmacokineticsStudies 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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00556998
Sponsor's protocol ID: A1501081
Status last verified: Mar 2016
First submitted: 9 Nov 2007
Last updated: 5 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Adolescents Aged 12 To <17 Years Who Are At High Risk For Systemic Fungal Infection
ClinicalTrials.gov ID: NCT00556998
Acronym / sponsor ID: A1501081
Conditions: Pharmacokinetics
Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 12 Nov 2007 (estimated)
Results: Posted 16 Mar 2012

Clinical summary

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

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Voriconazole

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Subjects who are expected to develop neutropenia following chemotherapy.
Subjects who require treatment for the prevention of systemic fungal infection.

Key exclusion criteria (2 listed)

Subjects with a history of severe intolerance of azole antifungal agents.
Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.

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: VfendVoriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.	Drug	1

Primary outcome

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
Time to Reach Cmax (Tmax) Following IV Administration
Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
AUC12,ss Following Oral Administration
Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Cmax,ss Following Oral Administration
Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Tmax Following Oral Administration
Time frame: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose

10 secondary outcomes

AUC12 Following IV Loading Dose
Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Tmax Following an IV Loading Dose
Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Cmax Following an IV Loading Dose
Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame: On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

Results and safety

Results posted to the registry on 16 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Treatments	26	21

Primary outcome: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration

Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion. Geometric mean (Standard Deviation). Unit: μg*h/mL

Measure	Voriconazole IV n = 23
Value	22.39 (21.47)

Population analysed: Intent to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.

Primary outcome: Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration

Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion. Geometric mean (Standard Deviation). Unit: μg/mL

Measure	Voriconazole IV n = 23
Value	3.89 (2.59)

Population analysed: ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Primary outcome: Time to Reach Cmax (Tmax) Following IV Administration

Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion. Median (Full Range). Unit: hours

Measure	Voriconazole IV n = 23
Value	1.30 (1.17 to 3.95)

Population analysed: ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Primary outcome: AUC12,ss Following Oral Administration

Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose. Geometric mean (Standard Deviation). Unit: μg*h/mL

Measure	Voriconazole Oral n = 19
Value	16.74 (13.50)

Population analysed: ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voriconazole IV	4 of 26 (15.4%)	26 of 26 (100%)	Not reported
Voriconazole Oral	4 of 22 (18.2%)	22 of 22 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Voriconazole in people with Pharmacokinetics, run by Pfizer at 9 sites 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 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 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Mar 2012). 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?

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration (time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion). The study lists 6 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 NCT00556998.

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 5 May 2016.