Skip to main content
OpenTrials
Completed

NCT Number: NCT00940017

A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aspergillosis Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Hartford, Connecticut, 06102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult subjects willing to comply with the study requirement.

Exclusion criteria

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

Treatment and study plan

anidulafungin and voriconazole

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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).

  10. 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.

  11. 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).

  12. 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.

  13. 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).

  14. 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.

  15. 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).

  16. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 15, 2009
Registry last updated
Feb 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.