NCT00150319

An Open-Label Study To Assess The Pharmacokinetics, Safety And Toleration Of Vfend®; Following Multiple Dosing With Vfend

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure

Interventions

Type	Name	Description
DRUG	Vfend®; I.V.

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-09-08
• Last updated: 2008-09-29

Locations

6 sites across 1 country: United States