Healthy Volunteers Clinical Trial
Official title:
A Phase I, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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