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NCT01660477 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01660477 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 68 participants.
The verdict
NCT01660477, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study 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.
Interventions
- DRUG Isavuconazole
- DRUG Lopinavir/ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01660477
The ClinicalTrials.gov registry entry for NCT01660477 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Isavuconazole is the first listed.
NCT01660477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01660477 about?
NCT01660477 is a clinical study titled "Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole". 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 r...
What is the current status of trial NCT01660477?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2012-06. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01660477?
The interventions under investigation include: Isavuconazole (DRUG), Lopinavir/ritonavir (DRUG).
Who is sponsoring clinical trial NCT01660477?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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