A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection

NCT00784368 | Completed Phase 3 Results DMC

• 2 other identifiers: CR014299JK1211-JPN-07
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia

Keywords

Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia; Itraconazole; JK1211

Outcome Measures

Primary Outcomes (6)

• Maximum Plasma Itraconazole Concentration (Cmax)

  The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).

  Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment

• Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])

  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.

  Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment

• Minimum Inhibitory Concentration (MIC)

  The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.

  Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment

• Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)

  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.

  Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment

• Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)

  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.

  Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment

• Time Above Minimum Inhibitory Concentration (T>MIC)

  The T\>MIC was calculated only in participants for whom the MIC was obtained.

  Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment

Secondary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• Number of Participants With Mycological Efficacy 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)

Study Arms (3)

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.

Drug: ITCZ Oral Solution

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.

Drug: ITCZ Oral Solution; Drug: ITCZ-IV

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.

Drug: ITCZ Oral Solution; Drug: ITCZ-IV

Interventions

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

Also known as: Itrizole Oral Solution 1%, JK1211

FN (Switched treatment); SFI (ITCZ Oral Solution Monotherapy); SFI (Switched Treatment)

ITCZ-IV DRUG

200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days

FN (Switched treatment); SFI (Switched Treatment)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

Related Links

• A Pharmacokinetics Study of JK1211 in Patient with "Deep Mycosis" and Those with "Febrile Neutropenia Suspected of Fungal Infection "

MeSH Terms

Conditions

Mycoses; Candidiasis; Aspergillosis; Cryptococcosis; Blastomycosis; Histoplasmosis; Neutropenia

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Dermatomycoses; Lung Diseases, Fungal; Respiratory Tract Infections; Skin Diseases, Infectious; Lung Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Results Point of Contact

• Title: Director, Established Products
• Organization: Global Medical Organization; Janssen R&D

(609) 730-7674

Study Officials

• Janssen Pharmaceutical K.K.,Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: November 3, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 25, 2013
• Results First Posted: July 25, 2013

Record last verified: 2013-06

Locations

JP (1)