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Sponsored by: |
Janssen Pharmaceutical K.K. |
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Information provided by: | Janssen Pharmaceutical K.K. |
ClinicalTrials.gov Identifier: | NCT00784368 |
The purpose of this study is to determine blood concentrations of itraconazole to assess the pharmacokinetics (the extent and rate of absorption, distribution, metabolism and excretion) of JK1211 in patients with deep mycosis and those with febrile neutropenia suspected of fungal infection.
Condition | Intervention | Phase |
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Aspergillosis Candidiasis Blastomycosis Cryptococcosis Mycoses Histoplasmosis Neutropenia) |
Drug: itraconazole (IV) Drug: JK1211 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Pharmacokinetics Study of JK1211 in Patient With "Deep Mycosis" and Those With "Febrile Neutropenia Suspected of Fungal Infection " |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: JK1211
20 mL to 40 mL daily for 7days up to 12 weeks
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002: No Intervention |
Drug: itraconazole (IV)
200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days
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Itraconazole, a triazole derivative, has a broad spectrum of antifungal activities. In Japan, capsules, oral solution and injectable solution containing itraconazole are available. The capsules were approved for the treatment of deep mycosis, oral solution was approved for the treatment of oropharyngeal candidiasis and esophageal candidiasis, and the injectable solution was approved for the treatment of deep mycosis and febrile neutropenia due to a suspected fungal infection. The oral solution (JK1211) is expected to be effective in and useful for patients who have difficulty taking meals or those take concomitant antacids. This is a multicenter, open-label (both physician and patient know the name of the study drug), uncontrolled (no competitive drugs involved) study to determine blood concentrations of itraconazole to assess the pharmacokinetics of JK1211 in patients with deep mycosis and those with febrile neutropenia suspected of fungal infection. The patients with deep mycosis will receive treatment with JK1211 or switch treatment from intravenous itraconazole to JK1211 at investigator's discretion. All of those with febrile neutropenia suspected of fungal infection will receive the switch treatment from intravenous itraconazole to JK1211. The patients will receive 20 mL of JK1211 once daily for at least 7days (up to 12 weeks) without prior itraconazole infusion, and those on the switch treatment will receive 20 mL of JK1211 twice daily for at least 7days (up to 12 weeks) after intravenous infusion of itraconazole (200 mg) twice for 2days and once for the next 1 to 12 days. The daily amount of JK1211 may be changed either 20 mL once, or 15 mL or 20 mL twice at investigator's discretion. Assessments of pharmacokinetics consist of determination of blood concentrations of itraconazole to assess the pharmacokinetics of JK1211 through 12 weeks. Fot the pharmacokinetic assessments, the patients will have blood drawn before and 1, 2, 4 and 8 weeks after the initiation of JK1211 treatment, and at the completion of the treatment, and those on the switch treatment will have additional blood draw before the initiation of intravenous itraconazole. Assessments of effectiveness consist of improvement of clinical symptoms, mycological efficacy, serologic efficacy against fungi, improvement of endoscopy/diagnostic imaging. Assessments of safety consist of the incidence of adverse events throughout the study, vital signs (pulse, blood pressure), electrocardiography and clinical laboratory tests.
The patients will receive 20 mL of JK1211 twice daily for at least 7days (up to 12 weeks) after intravenous infusion of itraconazole (200 mg) twice for 2days and once for the next 1 to 12 days. Some of those with deep mycosis will receive 20 mL of JK1211 once daily for at least 7days (up to 12 weeks) without prior itraconazole infusion at investigator's discretion. The daily amount of JK1211 may be changed either 20 mL once, or 15 mL or 20 mL twice at investigator's discretion.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Japan | |
Recruiting | |
812-0054, Japan |
Study Director: | Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. |
Responsible Party: | Janssen Pharmaceutical K.K. ( Director ) |
Study ID Numbers: | CR014299, JK1211-JPN-07 |
Study First Received: | October 23, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00784368 |
Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Blastomycosis Deep mycosis Fungal Infection Histoplasmosis Aspergillosis |
Febrile neutropenia Cryptococosis Neutropenia Itraconazole Candidiasis |
Candidiasis Skin Diseases Clotrimazole Hematologic Diseases Miconazole Blastomycosis Histoplasmosis Tioconazole Agranulocytosis Leukocyte Disorders Aspergillosis |
Hydroxyitraconazole Itraconazole Granulocytopenia Fever Mycoses Neutropenia Skin Diseases, Infectious Leukopenia Cryptococcosis Dermatomycoses |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Therapeutic Uses |
Antifungal Agents Infection Pharmacologic Actions |