Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ITCZ Oral Solution
ITCZ · 1 trial · 7 indications
The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).
The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg\*hour(hr) per ml.
The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.
The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.
The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.
The T\>MIC was calculated only in participants for whom the MIC was obtained.
| Arm | Type | Description |
|---|---|---|
| SFI (ITCZ Oral Solution Monotherapy) | EXPERIMENTAL | Participants with deep-seated mycosis (Systemic Fungal Infection \[SFI\]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion. |
| SFI (Switched Treatment) | EXPERIMENTAL | Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion. |
| FN (Switched treatment) | EXPERIMENTAL | Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| ITCZ Oral Solution | DRUG | 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 |
| ITCZ-IV | DRUG | 200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days |
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 feb...
ITCZ is an oral solution formulation of itraconazole, a small molecule antifungal developed by Johnson & Johnson under the ticker JNJ. It is being studied in Phase 3 for mycoses, a group of fungal infections that includes candidiasis, aspergillosis, cryptococcosis, blastomycosis, and histoplasmosis.
ITCZ is used for mycoses, which are fungal infections. The Phase 3 trial for ITCZ enrolled participants with deep mycosis and those with febrile neutropenia suspected of fungal infection. The conditions studied include candidiasis, aspergillosis, cryptococcosis, blastomycosis, histoplasmosis, and neutropenia.
ITCZ is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is responsible for the clinical development of ITCZ, including the Phase 3 pharmacokinetic study conducted in Japan.
ITCZ is in Phase 3 clinical development. The Phase 3 trial for ITCZ has been completed. ITCZ is an investigational drug and has not been approved by the FDA for any indication based on the available information.
ITCZ has been studied in one Phase 3 clinical trial, NCT00784368, titled "A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection." This trial is completed and enrolled 55 participants in Japan.
Yes, ITCZ is also known as ITCZ Oral Solution. Both names refer to the same oral solution formulation of itraconazole developed by Johnson & Johnson for the treatment of mycoses.