Phase 4
N=24
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
Aspergillosis · Candidemia
Bottom Line
View on ClinicalTrials.gov: NCT00940017 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) — 6.56; 5.32 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- anidulafungin and voriconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) |
6.56; 5.32 | — |
| PRIMARY Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax) |
1.93; 1.74 | — |
| PRIMARY Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau) |
101; 39.5 | — |
| PRIMARY Plasma PK: Plasma Elimination Half-life (t1/2) |
20.8; 6.94 | — |
| PRIMARY Plasma PK: Total Clearance (CL Total) |
17.1; 172 | — |
| PRIMARY Plasma PK: Volume of Distribution at Steady-state (Vss) |
30.8; 110 | — |
| PRIMARY Epithelial Lining Fluid (ELF) PK: Cmax |
1.13; 48.3 | — |
| PRIMARY ELF PK: Tmax |
24.0; 4.0 | — |
| PRIMARY ELF PK: AUCtau |
21.9; 282 | — |
| PRIMARY ELF PK: t1/2 |
— | — |
| PRIMARY Alveolar Macrophages (AM): Cmax |
103; 20.5 | — |
| PRIMARY AM: Tmax |
24; 4.0 | — |
| PRIMARY AM: AUCtau |
1430; 178 | — |
| PRIMARY AM: t1/2 |
— | — |
| PRIMARY Overall Drug Penetration Ratio in ELF |
0.22; 7.14 | — |
| PRIMARY Concentration Ratio in ELF to Plasma |
0.15; 0.15; 0.20; 0.38; 9.50; 4.93 | — |
Summary
The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00940017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.