NCT01494597

Drug Interaction Study of Isavuconazole and Cyclosporine

Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Cyclosporine: A Phase 1, Open-Label, Sequential Study in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of cyclosporine in healthy adult subjects.

Detailed description

Subjects will be enrolled to receive a single dose of cyclosporine on Day 1 followed by a 10-day wash-out period (time from cyclosporine dosing to isavuconazole dosing). On Days 11 and 12, isavuconazole will be dosed three times daily (TID). On Days 13 through 18, isavuconazole will be administered once daily (QD). All subjects will be administered a single dose of cyclosporine on Day 15. Subjects will be confined in the study center from Day -1 until Day 5 and from Day 10 until Day 19. A follow up visit will be scheduled approximately 7 ± 2 days after final dosing of isavuconazole. Blood and urine samples will be taken at various times during the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	isavuconazole	oral
DRUG	cyclosporine	oral

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-12-19
• Last updated: 2011-12-19

Locations

1 site across 1 country: United States