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A Phase 1 Open-Label Mass Balance Study to Evaluate the Pharmacokinetics of BAL8728 After A Single Intravenous Dose of 14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product (BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of BAL8728 in human plasma, urine and/or feces after a single intravenous dose of pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815. Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled isavuconazonium sulfate will also be evaluated.
Details
| Lead sponsor | Astellas Pharma Global Development, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2013-04 |
| Completion | 2013-04 |
Conditions
- Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate
- Healthy Subjects
Interventions
- Pyridinylmethyl-14C-labeled isavuconazonium sulfate
Primary outcomes
- Radioactivity in whole blood and in plasma: Area under the concentration-time curve (AUC) from time of dosing to infinity (AUCinf) — 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
- Radioactivity in whole blood and in plasma: AUC from time of dosing to the last quantifiable concentration (AUClast) — 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
- Radioactivity in whole blood and in plasma: Maximum concentration (Cmax) — 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
- Radioactivity in whole blood and in plasma: Time to Attain Cmax (tmax) — 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
- Radioactivity in whole blood and in plasma: Apparent terminal elimination half-life (t1/2) — 20 time points up to Day 4. If Day 4 is not the end of the study, samples will be drawn once a day up to Day 9
- Radioactivity in emesis (if applicable) — After study drug administration up to Day 9
Countries
United States