Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza (FROSTY)
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|ClinicalTrials.gov Identifier: NCT02014649|
Recruitment Status : Terminated (Study was terminated as per BARDA decision to terminate contract.)
First Posted : December 18, 2013
Last Update Posted : April 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: 20 mg laninamivir octanoate Drug: Placebo Drug: 40 mg laninamivir octanoate||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Experimental: 20mg Laninamivir Octanoate
Dry Powder plus placebo
Drug: 20 mg laninamivir octanoate
Other Name: CS-8958
Other Name: Lactose
Experimental: 40mg Laninamivir Octanoate
Drug: 40 mg laninamivir octanoate
Other Name: CS-8958
- To evaluate the safety and tolerability of laninamivir octanoate following administration of the dose by inhalation in children with influenza A or B infection [ Time Frame: Subjects are assessed at clinic visits and followed up to 28-days post dose. ]Safety data will be presented according to dose group and age strata. All safety data will be summarized with descriptive statistics, and include assessment of SAEs, AEs, Clinically Significant changes in routine labs, O2 Saturation, ECG, Vitals, Con Meds, Physical Exam findings.
- To evaluate the pharmacokinetic (PK) profiles of the prodrug, laninamivir octanoate, and its active metabolite, laninamivir, following administration of a single dose (20 or 40 mg) [ Time Frame: Samples are collected at clinic visits over 5 days. ]Pharmacokinetic parameters will be calculated and summarized, PK concentration data will add to population models.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014649
|Study Director:||Jolanta Airey, Dr||Biota Scientific Management Pty Ltd|