Drug Interaction Study of Isavuconazole and Midazolam
Tracking Information | |||||
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First Received Date ICMJE | July 6, 2011 | ||||
Last Updated Date | July 28, 2011 | ||||
Start Date ICMJE | May 2011 | ||||
Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01406171 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Drug Interaction Study of Isavuconazole and Midazolam | ||||
Official Title ICMJE | A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects | ||||
Brief Summary | The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects. |
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Detailed Description | Subjects will check-in on Day -1 and remain confined to the study center until the completion of study procedures on Day 14. Subjects will return to the study center for an outpatient follow-up visit on Day 21. Blood and urine samples will be taken at various times during the study. Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4, isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13, isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup will be administered on Day 12. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | Experimental: Isavuconazole and Midazolam
Isavuconazole three times per day (TID) for 2 days followed by once a day (QD) for 9 days. Midazolam single doses on days 1 and 12
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 24 | ||||
Completion Date | June 2011 | ||||
Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406171 | ||||
Other Study ID Numbers ICMJE | 9766-CL-0023 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Clinical Trials Registry, Astellas Pharma Global Development | ||||
Study Sponsor ICMJE | Astellas Pharma Inc | ||||
Collaborators ICMJE | Basilea Pharmaceutica | ||||
Investigators ICMJE |
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Information Provided By | Astellas Pharma Inc | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |