Status:
COMPLETED
A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Mycoses
Candidiasis
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) or...
Detailed Description
This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than 1 center) and uncontrolled (no competitive drugs involved) study. Participants with SFI wi...
Eligibility Criteria
Inclusion
- In case of participants with deep-seated mycosis (systemic fungal infection \[SFI\]) they should be either clinically suspected case or proven case
- All participants administered need to be hospitalized during the itraconazole intravenous treatment
- For participants with febrile (with fever) neutropenia (a decrease in white blood cells) suspected of fungal infection who have persistent fever (greater than equal to 37.5 degree celsius; greater than equal to 3 days) and have neutrophil count less than 500 per cubic millimeter (or less than 1000 per cubic millimeter and expected to decrease toward less than 500 per cubic millimeter
Exclusion
- No past history of hypersensitivity to azole antifungal agents
- No current medication with antifungal agents such as amphotericin B (intravenous injection \[injection of a substance into a vein\], tablets, syrup), nystatin (tablets), fluconazole (capsules, intravenous injection), flucytosine (oral agent), miconazole (intravenous injection, gel), micafungin (intravenous infusion), fosfluconazole (intravenous injection,) voriconazole (intravenous injection, tablets), liposomal amphotericin B (intravenous injection), posaconazole
- No medication with itraconazole in any formulation within the last 28 days
- Participants with history of severe hepatic disease (except hepatic dysfunction because of fungal infection) and congestive heart failure
- Female participants who are either pregnant, nursing, suspected to be pregnant or will become pregnant during the trial duration
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00784368
Start Date
January 1 2008
End Date
May 1 2009
Last Update
July 25 2013
Active Locations (1)
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1
Fukuoka, Japan