NCT01555866

Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.

A Phase 1 Open Label, 2 Part, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.

Detailed description

In Part 1, eligible subjects will be enrolled into one of 2 groups based on their renal function. All subjects will receive a single 1-hour infusion of isavuconazole and will remain confined for 4 days. Subjects with normal renal function will return to the clinic for several outpatient visits over 15 days after dosing. Subjects with renal disease will complete the same outpatient visits which correspond to scheduled dialysis dates and then be readmitted to the clinic on study Day 15 to receive a second 1-hour infusion of isavuconazole followed by their normal dialysis procedure and then remain confined for 4 days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in the body as well as study drug removed in subjects undergoing dialysis. In Part 2, eligible subjects will be enrolled into one of 4 groups based on their renal function. All subjects will receive a single 1-hour infusion of isavuconazole and remain confined for 4 days. Subjects will return to the clinic for several outpatient visits over 15 days after dosing. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in the body.

Conditions

• Pharmacokinetics of Isavuconazole
• Healthy Volunteers
• Renal Impaired

Interventions

Type	Name	Description
DRUG	isavuconazole	IV

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-03-16
• Last updated: 2015-09-01

Locations

3 sites across 1 country: United States