A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
NCT01884636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2013-06-24
Summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate. Safety and tolerability of isavuconazole will be assessed alone and in combination with methotrexate.
Conditions
- Pharmacokinetics of Isavuconazole
- Pharmacokinetics of Methotrexate
- Pharmacokinetics of 7-hydroxymethotrexate
- Healthy Subjects
Interventions
- DRUG
-
isavuconazole
oral
- DRUG
-
methotrexate
oral
Sponsors & Collaborators
-
Basilea Pharmaceutica International Ltd
collaborator INDUSTRY -
Astellas Pharma Global Development, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma Global Development, Inc.
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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