Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 investigational small molecule being developed for the treatment of mycoses, including candidiasis, aspergillosis, cryptococcosis, blastomycosis, and histoplasmosis. It is also being studied in patients with febrile neutropenia suspected of fungal infection. The drug is currently in Phase 3 clinical development.
ITCZ is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The drug is currently in Phase 3 clinical development for the treatment of mycoses.
ITCZ is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, and the drug is being studied for the treatment of mycoses.
ITCZ has one completed Phase 3 clinical trial, NCT00784368, which was a pharmacokinetic study of JK1211 (itraconazole [Itrizole]) oral solution in participants with deep mycosis and those with febrile neutropenia suspected of fungal infection. The trial enrolled 55 participants in Japan.
Yes, ITCZ is also known as JK1211. In clinical trial NCT00784368, the drug is referred to as JK1211, which is itraconazole (Itrizole) oral solution. This alternative name is used in the context of the Phase 3 pharmacokinetic study.