Fungal Infection Clinical Trial
Official title:
Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05520)
The purpose of this study is to collect pharmacokinetic (PK) information related to how well
intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and
tolerability of this new formulation. In addition, the PK, safety, and tolerability of
switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be
evaluated. The data collected in this study will be compared to data collected in previous
studies.
Individuals who have been diagnosed by their physicians with a blood disease or cancer that
can affect their infection-fighting white blood cells will be asked to participate in the
trial. Since these blood diseases and their treatments can weaken the immune system, they may
put these individuals at a high risk for getting a serious fungal infection of their internal
organs or blood (invasive fungal infection). As these fungal infections can be hard to detect
early and can be life-threatening, many physicians believe that individuals diagnosed with
these diseases should receive antifungal therapy to try to lower their risk of getting this
type of infection.
Enrollment into this study will take place in several stages (cohorts). The determination of
which cohort an individual will be asked to participate in is based on which cohort is open
at the site at the time the individual is approached to consider study participation.
n/a
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