AspergillosisPhase 4NCT00940017

A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects

A Phase 4 study testing anidulafungin and voriconazole in people with Aspergillosis and Candidemia, 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.

Official record

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Trial summary

The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Aspergillosis, Candidemia
What is being tested?: anidulafungin and voriconazole
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Oct 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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult subjects willing to comply with the study requirement.

Who cannot join

Clinical significant disease.
Sensitive to study medication.
Not willing to comply with the study requirement.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Hartford, Connecticut, 06102

Other trials in United States

About this study

Official title: A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects

The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.

Conditions: Aspergillosis, Candidemia
Being tested: anidulafungin and voriconazole
Keywords: PK, fungal infection
Medical subject headings: Aspergillosis, Candidemia, Mycoses

What participants receive

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

anidulafungin and voriconazoleDrug
Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.

Study groups in NCT00940017
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: anidulafungin and voriconazole

What is being measured

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

Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.
Measured: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.
Measured: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)
AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.
Measured: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Plasma PK: Plasma Elimination Half-life (t1/2)
t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.
Measured: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Plasma PK: Total Clearance (CL Total)
CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.
Measured: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Plasma PK: Volume of Distribution at Steady-state (Vss)
Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.
Measured: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Epithelial Lining Fluid (ELF) PK: Cmax
Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).
Measured: 4, 8, 12, 24 hours after start of infusion
ELF PK: Tmax
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.
Measured: 4, 8, 12, 24 hours after start of infusion
ELF PK: AUCtau
AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Measured: 4, 8, 12, 24 hours after start of infusion
ELF PK: t1/2
t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.
Measured: 4, 8, 12, 24 hours after start of infusion
Alveolar Macrophages (AM): Cmax
Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Measured: 4, 8, 12, 24 hours after start of infusion
AM: Tmax
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.
Measured: 4, 8, 12, 24 hours after start of infusion
AM: AUCtau
AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Measured: 4, 8, 12, 24 hours after start of infusion
AM: t1/2
t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.
Measured: 4, 8, 12, 24 hours after start of infusion
Overall Drug Penetration Ratio in ELF
ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Measured: 4, 8, 12, 24 hours after start of infusion
Concentration Ratio in ELF to Plasma
Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.
Measured: 4, 8, 12, 24 hours after start of infusion

Timeline

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

Sep 2008Oct 2008

First posted15 Jul 2009 (estimated)
Study startSep 2008
Primary completionOct 2008
Study completionOct 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.
Other trials for AspergillosisStudies 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
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00940017
Sponsor's protocol ID: A8851020
Status last verified: Jan 2010
First submitted: 13 Jul 2009
Last updated: 9 Feb 2010
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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Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
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All Aspergillosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects
ClinicalTrials.gov ID: NCT00940017
Acronym / sponsor ID: A8851020
Conditions: Aspergillosis, Candidemia
Keywords: PK, fungal infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 15 Jul 2009 (estimated)
Results: Posted 9 Feb 2010

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 provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.

Study design

Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: anidulafungin and voriconazole

Who may qualify

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

Key inclusion criteria (1 listed)

Healthy adult subjects willing to comply with the study requirement.

Key exclusion criteria (3 listed)

Clinical significant disease.
Sensitive to study medication.
Not willing to comply with the study requirement.

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
anidulafungin and voriconazoleSubjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.	Drug	1

Primary outcome

Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.
Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.
Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)
Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.
Plasma PK: Plasma Elimination Half-life (t1/2)
Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.
Plasma PK: Total Clearance (CL Total)
Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.
Plasma PK: Volume of Distribution at Steady-state (Vss)
Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.
Epithelial Lining Fluid (ELF) PK: Cmax
Time frame: 4, 8, 12, 24 hours after start of infusion
Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).
ELF PK: Tmax
Time frame: 4, 8, 12, 24 hours after start of infusion
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.
ELF PK: AUCtau
Time frame: 4, 8, 12, 24 hours after start of infusion
AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
ELF PK: t1/2
Time frame: 4, 8, 12, 24 hours after start of infusion
t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.
Alveolar Macrophages (AM): Cmax
Time frame: 4, 8, 12, 24 hours after start of infusion
Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
AM: Tmax
Time frame: 4, 8, 12, 24 hours after start of infusion
Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.
AM: AUCtau
Time frame: 4, 8, 12, 24 hours after start of infusion
AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
AM: t1/2
Time frame: 4, 8, 12, 24 hours after start of infusion
t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.
Overall Drug Penetration Ratio in ELF
Time frame: 4, 8, 12, 24 hours after start of infusion
ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
Concentration Ratio in ELF to Plasma
Time frame: 4, 8, 12, 24 hours after start of infusion
Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.

Results and safety

Results posted to the registry on 9 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anidulafungin and Voriconazole	24	20

Primary outcome: Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)

Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion. Mean (Standard Deviation). Unit: ug/mL

Measure	Anidulafungin and Voriconazole n = 20
Anidulafungin	6.56 (1.62)
Voriconazole	5.32 (1.82)

Population analysed: PK parameter analysis population

Primary outcome: Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)

Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion. Median (Full Range). Unit: hours

Measure	Anidulafungin and Voriconazole n = 20
Anidulafungin	1.93 (1.70 to 2.17)
Voriconazole	1.74 (1.67 to 2.05)

Population analysed: PK parameter analysis population

Primary outcome: Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)

Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion. Mean (Standard Deviation). Unit: ug*hr/mL

Measure	Anidulafungin and Voriconazole n = 20
Anidulafungin	101 (21.8)
Voriconazole	39.5 (19.8)

Population analysed: PK parameter analysis population defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest.

Primary outcome: Plasma PK: Plasma Elimination Half-life (t1/2)

Time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion. Mean (Standard Deviation). Unit: hours

Measure	Anidulafungin and Voriconazole n = 18
Anidulafungin (n=18)	20.8 (3.06)
Voriconazole (n=15)	6.94 (2.10)

Population analysed: PK parameter analysis population; (n) = number of subjects contributing to the mean

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anidulafungin and Voriconazole	0 of 21 (0%)	15 of 21 (71.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 anidulafungin and voriconazole in people with Aspergillosis and Candidemia, 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 1 inclusion and 3 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 9 Feb 2010. 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 9 Feb 2010). 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 Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) (time frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion). The study lists 16 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 NCT00940017.

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 9 Feb 2010.