NCT02014649

Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza

Randomised, Parallel Dose, Phase 1/2 Safety and Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Naturally Acquired Influenza A or B

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Biota Scientific Management Pty Ltd · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 48 subjects aged 5-17 years inclusive will be randomised into the study. Subjects with recent onset of presumptive influenza will have influenza A or B infection confirm by Rapid Antigen Test. The study will be conducted on an outpatient basis. The dose is administered in a single session in the clinic on Day 1. The subject will return to the clinic for assessments and follow up.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	20 mg laninamivir octanoate
DRUG	Placebo
DRUG	40 mg laninamivir octanoate

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2013-12-18
• Last updated: 2025-01-13
• Results posted: 2025-01-13

Locations

28 sites across 1 country: United States