Trials / Completed
CompletedNCT01711489
A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
A Phase 1, Open-Label, Sequential Study of the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration. Safety and tolerability of isavuconazole will be assessed alone and in combination with MMF.
Conditions
- Healthy Subjects
- Pharmacokinetics of Isavuconazole
- Pharmacokinetics of Plasma Mycophenolic Acid (MPA)
- Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | isavuconazole | oral |
| DRUG | Mycophenolate mofetil | oral |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2012-10-22
- Last updated
- 2012-10-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01711489. Inclusion in this directory is not an endorsement.