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
NCT00784368, Phase 3, Completed, Janssen Pharmaceutical K.K.; results first posted 2013-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection. Trials, record NCT00784368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784368
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection
- NCT number
- NCT00784368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Conditions
- Mycoses, Candidiasis, Aspergillosis, Cryptococcosis, Blastomycosis, Histoplasmosis, Neutropenia
- Interventions
- ITCZ Oral Solution, ITCZ-IV
- First posted
- 2008-11-03
- Last updated
- 2013-07-25
- Results first posted
- 2013-07-25
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Itraconazole Concentration (Cmax) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml). |
| Primary | Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24]) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | 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. |
| Primary | Minimum Inhibitory Concentration (MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. |
| Primary | Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | 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. |
| Primary | Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | 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. |
| Primary | Time Above Minimum Inhibitory Concentration (T>MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The T\>MIC was calculated only in participants for whom the MIC was obtained. |
| Secondary | Number of Participants With Change in Clinical Symptoms by Centralized Assessment | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment) | Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). |
| Secondary | Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment) | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment) | Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C). |
| Secondary | Percentage of Participants With Overall Response by Centralized Assessment | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment) | Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100. |
| Secondary | Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment) | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment) | E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Plasma Itraconazole Concentration (Cmax) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. | mcg/ml | MEAN |
| PRIMARY | Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24]) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. | mcg*hr per ml | MEAN |
| PRIMARY | Minimum Inhibitory Concentration (MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same. | mcg per ml | MEAN |
| PRIMARY | Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same. | ratio | MEAN |
| PRIMARY | Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same. | hour | MEAN |
| PRIMARY | Time Above Minimum Inhibitory Concentration (T>MIC) | Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment | The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same. | percent time | MEAN |
| SECONDARY | Number of Participants With Change in Clinical Symptoms by Centralized Assessment | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment) | FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses. | participants | NUMBER |
| SECONDARY | Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment) | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment) | The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Response by Centralized Assessment | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment) | The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment) | Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment) | The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group143
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Itraconazole Concentration (Cmax) | SFI (ITCZ Oral Solution Monotherapy) | 200 mg/day (n=11,5,12) | 2.90 | Standard Deviation 1.48 | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | SFI (Switched Treatment) | 200 mg/day (n=11,5,12) | 2.30 | Standard Deviation 1.12 | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | FN (Switched Treatment) | 200 mg/day (n=11,5,12) | 1.79 | Standard Deviation 0.682 | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | SFI (ITCZ Oral Solution Monotherapy) | 300 mg/day (n=4,2,0) | 9.20 | Standard Deviation 2.39 | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | SFI (Switched Treatment) | 300 mg/day (n=4,2,0) | 58.2 | Standard Deviation NA | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | FN (Switched Treatment) | 300 mg/day (n=4,2,0) | NA | Standard Deviation NA | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | SFI (ITCZ Oral Solution Monotherapy) | 400mg/day (n=1,6,10) | 0.948 | Standard Deviation NA | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | SFI (Switched Treatment) | 400mg/day (n=1,6,10) | 6.10 | Standard Deviation 3.12 | mcg/ml |
| Maximum Plasma Itraconazole Concentration (Cmax) | FN (Switched Treatment) | 400mg/day (n=1,6,10) | 2.44 | Standard Deviation 0.996 | mcg/ml |
| Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24]) | SFI (ITCZ Oral Solution Monotherapy) | 200 mg/day (n=11,5,12) | 55.8 | Standard Deviation 34.4 | mcg*hr per ml |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SFI (ITCZ Oral Solution Monotherapy) | 16 | |
| Overall Study | STARTED | SFI (Switched Treatment) | 16 | |
| Overall Study | STARTED | FN (Switched Treatment) | 23 | |
| Overall Study | COMPLETED | SFI (ITCZ Oral Solution Monotherapy) | 8 | |
| Overall Study | COMPLETED | SFI (Switched Treatment) | 5 | |
| Overall Study | COMPLETED | FN (Switched Treatment) | 12 | |
| Overall Study | NOT COMPLETED | SFI (ITCZ Oral Solution Monotherapy) | 8 | |
| Overall Study | NOT COMPLETED | SFI (Switched Treatment) | 11 | |
| Overall Study | NOT COMPLETED | FN (Switched Treatment) | 11 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | SFI (ITCZ Oral Solution Monotherapy) | 0 | 16 | |
| other | Nasopharyngitis | Infections and infestations | SFI (Switched Treatment) | 3 | 16 | |
| other | Nasopharyngitis | Infections and infestations | FN (Switched Treatment) | 1 | 23 | |
| other | Pancytopenia | Blood and lymphatic system disorders | SFI (ITCZ Oral Solution Monotherapy) | 1 | 16 | |
| other | Pancytopenia | Blood and lymphatic system disorders | SFI (Switched Treatment) | 0 | 16 | |
| other | Pancytopenia | Blood and lymphatic system disorders | FN (Switched Treatment) | 5 | 23 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | SFI (ITCZ Oral Solution Monotherapy) | 1 | 16 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | SFI (Switched Treatment) | 0 | 16 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | FN (Switched Treatment) | 3 | 23 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | SFI (ITCZ Oral Solution Monotherapy) | 3 | 16 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SFI (ITCZ Oral Solution Monotherapy) | ||
| Total, all-cause mortality | SFI (Switched Treatment) | ||
| Total, all-cause mortality | FN (Switched Treatment) | ||
| Total, other adverse events | SFI (ITCZ Oral Solution Monotherapy) | 15 | 16 |
| Total, other adverse events | SFI (Switched Treatment) | 16 | 16 |
| Total, other adverse events | FN (Switched Treatment) | 22 | 23 |
| Total, serious adverse events | SFI (ITCZ Oral Solution Monotherapy) | 4 | 16 |
| Total, serious adverse events | SFI (Switched Treatment) | 8 | 16 |
| Total, serious adverse events | FN (Switched Treatment) | 3 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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