Phase 3
N=55
A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
Mycoses · Candidiasis · Aspergillosis · Cryptococcosis · Blastomycosis
Bottom Line
View on ClinicalTrials.gov: NCT00784368 ↗Enrolled (actual)
55
Serious AEs
27.3%
Results posted
Jul 2013
Primary outcome: Primary: Maximum Plasma Itraconazole Concentration (Cmax) — 2.90; 2.30; 1.79; 9.20 mcg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ITCZ Oral Solution (Drug); ITCZ-IV (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Itraconazole Concentration (Cmax) |
2.90; 2.30; 1.79; 9.20; 58.2; NA | — |
| PRIMARY Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24]) |
55.8; 41.0; 31.4; 207; 129; NA | — |
| PRIMARY Minimum Inhibitory Concentration (MIC) |
0.438; 0.06; NA; 1.00; NA; 0.71 | — |
| PRIMARY Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC) |
7.21; 28.8; NA; 5.81; NA; 18.9 | — |
| PRIMARY Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC) |
147; 399; NA; 129; NA; 421 | — |
| PRIMARY Time Above Minimum Inhibitory Concentration (T>MIC) |
100; 100; NA; 100; NA; 100 | — |
| SECONDARY Number of Participants With Change in Clinical Symptoms by Centralized Assessment |
7; 6; 12; 12; 7; 2 | — |
| SECONDARY Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment) |
1; 3; 2; 1; 1; 1 | — |
| SECONDARY Percentage of Participants With Overall Response by Centralized Assessment |
62.1; 80.0; 58.1; 72.7 | — |
| SECONDARY Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment) |
100.0; 100.0; 60.0; 62.5; 50.0; 50.0 | — |
| SECONDARY Number of Participants With Mycological Efficacy by Centralized Assessment |
6; 0; 1; 0; 24; 22 | — |
| SECONDARY Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment) |
1; 1; 2; 5; 1; 1 | — |
| SECONDARY Number of Participants With Serological Effect Against Fungi by Centralized Assessment |
1; 0; 3; 0; 5; 1 | — |
| SECONDARY Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment) |
1; 3; 1; 1; 3; 2 | — |
| SECONDARY Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment |
3; 0; 12; 0; 7; 0 | — |
| SECONDARY Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment) |
1; 3; 3; 2; 3; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00784368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.