Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this two part study is to assess the effect of multiple doses of isavuconazole
on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple
doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.
Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or
isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate
safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir
on isavuconazole.
Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone,
lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.