Clinical trial NCT00784368: A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
Official title: A Pharmacokinetic Study of JK1211 in Patients With Systemic Fungal Infection (SFI) and Patients With Febrile Neutropenia (FN) Suspected of Fungal Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mycoses
Candidiasis
Aspergillosis
Cryptococcosis
Blastomycosis
Histoplasmosis
Neutropenia
Keywords: Mycoses
Candidiasis
Aspergillosis
Cryptococcosis
Blastomycosis
Histoplasmosis
Neutropenia
Itraconazole
JK1211
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) 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.

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 will receive treatment with ITCZ oral solution or switch treatment from intravenous (into a vein) infusion of itraconazole (ITCZ-intravenous) to ITCZ oral solution as per Investigator's discretion. All the participants with FN suspected of fungal infection will receive the switch treatment from ITCZ- intravenous to ITCZ oral solution. The study will include 3 periods: Pre-observation period (7 days), Treatment period (85 days for ITCZ oral solution monotherapy and 99 days for switch treatment) and Follow-up observation period (30 days). The participants who receive ITCZ oral solution monotherapy will receive ITCZ oral solution without ITCZ-intravenous in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks (85 days) and those on the switch treatment will receive 400 milligram (mg) per day ITCZ-intravenous twice for first 2 days followed by 200 mg per day ITCZ-intravenous up to 14 days and then they will be administered treatment as per ITCZ oral solution monotherapy. Efficacy will primarily be evaluated by assessing the pharmacokinetics. Participants' safety will be monitored throughout the study.

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

Primary outcomes:
measure: Maximum Plasma Itraconazole Concentration (Cmax)
timeFrame: Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
measure: Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])
timeFrame: Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
measure: Minimum Inhibitory Concentration (MIC)
timeFrame: Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
measure: Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)
timeFrame: Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
measure: Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)
timeFrame: Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
measure: Time Above Minimum Inhibitory Concentration (T>MIC)
timeFrame: Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment
Secondary outcomes:
measure: Number of Participants With Change in Clinical Symptoms by Centralized Assessment
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
measure: Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
measure: Percentage of Participants With Overall Response by Centralized Assessment
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
measure: Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
measure: Number of Participants With Mycological Efficacy by Centralized Assessment
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
measure: Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
measure: Number of Participants With Serological Effect Against Fungi by Centralized Assessment
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
measure: Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
measure: Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)
measure: Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)
timeFrame: Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K.,Japan Clinical Trial
role: STUDY_DIRECTOR
References: