A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
Condition: Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia
MeSH terms: Mycoses; Candidiasis; Aspergillosis; Histoplasmosis; Cryptococcosis; Blastomycosis; Neutropenia; Febrile Neutropenia
Intervention: ITCZ Oral Solution; ITCZ-IV
Intervention description: ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks; 200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia; Itraconazole; JK1211

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) oral solution in participants with Systemic Fungal Infection (SFI) and
      those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of
      fungal infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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