drugset
drugset / Trial / NCT04096157

A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants

NCT04096157 ↗

Phase 1 Completed 17 enrolled Astellas Pharma Global Development, Inc.
RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants)(reference formulation). In addition, this study will evaluate the safety and tolerability of isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) and a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions in healthy male and female participants.

Timeline

Start
2019-09-24
Primary completion
2020-01-16
Completion
2020-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Isavuconazonium Small molecule — Intravenous

Indications

No indication recorded.