A Pharmacokinetics Study of JK1211, Itraconazole Oral Solution, in Patients With Deep Mycosis and Those With Febrile Neutropenia Due to a Suspected Fungal Infection

• Pharmacokinetic parameters through 12 weeks [ Time Frame: From the begining to end of treatment period (12 weeks). ] [ Designated as safety issue: No ]
  

• Effectiveness assessments through 12 weeks including improvement of clinical symptoms, mycological efficacy, serologic efficacy against fungi and improvement of endoscopy/diagnostic imaging; Safety assessments throughout the study. [ Time Frame: For effectiveness assessments, from the begining to end of treatment period (12 weeks); For safety assessments, thoughout the study. ] [ Designated as safety issue: Yes ]
  

Itraconazole, a triazole derivative, has a broad spectrum of antifungal activities. In Japan, capsules, oral solution and injectable solution containing itraconazole are available. The capsules were approved for the treatment of deep mycosis, oral solution was approved for the treatment of oropharyngeal candidiasis and esophageal candidiasis, and the injectable solution was approved for the treatment of deep mycosis and febrile neutropenia due to a suspected fungal infection. The oral solution (JK1211) is expected to be effective in and useful for patients who have difficulty taking meals or those take concomitant antacids. This is a multicenter, open-label (both physician and patient know the name of the study drug), uncontrolled (no competitive drugs involved) study to determine blood concentrations of itraconazole to assess the pharmacokinetics of JK1211 in patients with deep mycosis and those with febrile neutropenia suspected of fungal infection. The patients with deep mycosis will receive treatment with JK1211 or switch treatment from intravenous itraconazole to JK1211 at investigator's discretion. All of those with febrile neutropenia suspected of fungal infection will receive the switch treatment from intravenous itraconazole to JK1211. The patients will receive 20 mL of JK1211 once daily for at least 7days (up to 12 weeks) without prior itraconazole infusion, and those on the switch treatment will receive 20 mL of JK1211 twice daily for at least 7days (up to 12 weeks) after intravenous infusion of itraconazole (200 mg) twice for 2days and once for the next 1 to 12 days. The daily amount of JK1211 may be changed either 20 mL once, or 15 mL or 20 mL twice at investigator's discretion. Assessments of pharmacokinetics consist of determination of blood concentrations of itraconazole to assess the pharmacokinetics of JK1211 through 12 weeks. For the pharmacokinetic assessments, the patients will have blood drawn before and 1, 2, 4 and 8 weeks after the initiation of JK1211 treatment, and at the completion of the treatment, and those on the switch treatment will have additional blood draw before the initiation of intravenous itraconazole. Assessments of effectiveness consist of improvement of clinical symptoms, mycological efficacy, serologic efficacy against fungi, and improvement of endoscopy/diagnostic imaging. Assessments of safety consist of the incidence of adverse events throughout the study, vital signs (pulse, blood pressure), electrocardiography and clinical laboratory tests. The patients will receive 20 mL of JK1211 twice daily for at least 7days (up to 12 weeks) after intravenous infusion of itraconazole (200 mg) twice for 2days and once for the next 1 to 12 days. Some of those with deep mycosis will receive 20 mL of JK1211 once daily for at least 7days (up to 12 weeks) without prior itraconazole infusion at investigator's discretion. The daily amount of JK1211 may be changed either 20 mL once, or 15 mL or 20 mL twice at investigator's discretion.