Trials / Completed
CompletedNCT01660477
Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
A Phase 1, Open-Label, Parallel Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Multiple Doses of Lopinavir/Ritonavir and the Effects of Lopinavir/Ritonavir on the Pharmacokinetics of Multiple Doses of Isavuconazole in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this two part study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole. Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir on isavuconazole. Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone, lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isavuconazole | oral |
| DRUG | Lopinavir/ritonavir | oral |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2012-10-01
- Completion
- 2012-10-01
- First posted
- 2012-08-08
- Last updated
- 2015-02-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01660477. Inclusion in this directory is not an endorsement.