An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend®; I.V. In Subjects With Moderately Impaired Renal Function
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 1
- Locations
- 6
- Primary Endpoint
- Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency
Study Overview
Brief Summary
This is a study to investigate the pharmacokinetics, safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency
Detailed Description
The study was put on hold after the first subject was enrolled and experienced a serious adverse event (SAE) of renal failure chronic after receiving his I.V. dose on Day 1. The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related; however, the site was unwilling to enroll additional subjects. Another site, based in New Orleans, was damaged by hurricane Katrina and was unable to enroll any subjects. A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with moderate renal insufficiency
Exclusion Criteria
- •Active infection
Outcomes
Primary Outcomes
Ability to tolerate up to seven days of intravenous voriconazole without worsening of pre-existing renal insufficiency
Secondary Outcomes
No secondary outcomes reported