drugset / Trial / NCT02014649
Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
Phase 1/2
Terminated
15 enrolled
Biota Scientific Management Pty Ltd
Department of Health and Human Services · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
Timeline
- Start
- 2013-11
- Primary completion
- 2014-04
- Completion
- 2014-05
Outcome
Outcome not reported
Stopped: “Study was terminated as per BARDA decision to terminate contract.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Laninamivir Octanoate | Small molecule | 20 mg | Inhaled |
| Subject | Laninamivir Octanoate | Small molecule | 40 mg | Inhaled |