NCT01555918

A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers

A Phase I, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic properties of isavuconazole (BAL4815) and the cleavage product (BAL8728) and assess the safety and tolerability after single-dose and steady state (multiple-dose) administration of isavuconazole BAL8557 in healthy Chinese subjects.

Detailed description

This is a two part study: Part 1: On Day 1, Period 1, subjects will receive a single dose of isavuconazole orally or intravenously according to the treatment sequence allocation. Subjects will remain resident in the unit in order to collect blood for pharmacokinetics (PK) and to assess the safety tests. They will be released in the morning of Day 15 after collection of blood for safety tests. Subjects will have a washout period of 2 weeks returning to the unit for Day -1 of Period 2 (Day 29). Subjects will receive a single dose of isavuconazole orally or intravenously (opposite mode of administration from Period 1). Subjects will remain resident in the unit and will be released in the morning of Day 15, Period 2 (Day 44) after collection of blood for tests. Part 2: Subjects will be allocated to multiple intravenous (IV) (Group 1) or oral (Group 2) dosing. On Day 1, Group 1 will receive multiple intravenous (IV) dosing of isavuconazole as a 2-hour infusion, three times a day (TID) with 8 hours between doses for 2 days followed by isavuconazole as a 2-hour infusion every day (QD) for 10 days. Group 2 will receive multiple oral (PO) dosing of isavuconazole TID with 8 hours between doses for 2 days followed by isavuconazole PO QD for 10 days. Subjects in Group 1 and 2 will remain resident in the unit in order to collect blood and urine for PK evaluations and to assess the safety tests. They will be released in the morning of Day 26 after collection of blood for tests.

Conditions

• Pharmacokinetics of BAL4815
• Pharmacokinetics of BAL8728
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Isavuconazole	oral
DRUG	Isavuconazole (IV)	intravenous (IV)

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-03-16
• Last updated: 2013-02-01

Locations

1 site across 1 country: China