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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
To Evaluate Time to First Alleviation of a Composite of Influenza Symptoms and Absence of Fever.
For subjects aged 5 through 12 years, the subject or parent/legal guardian completed the Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom diary and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit. Subjects aged 13 through 17 years completed the Influenza Symptom Questionnaire (ISQ) themselves and measured otic body temperature twice a day, in the morning between 6 and 10AM and evening between 6 and 10PM, until the Day 10 visit.
Time frame: Subjects are assessed at clinic visits and followed up to 28-days post dose.
To Evaluate the Pharmacokinetic (PK) Profiles (Concentration) of the Prodrug, Laninamivir Octanoate, and Its Active Metabolite, Laninamivir, Following Administration of a Single Dose (20 or 40 mg)
Pharmacokinetic parameters will be calculated and summarized, PK concentration data will add to population models.
Time frame: Samples are collected at clinic visits over 5 days.
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Precision Trials LLC
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
SoCal Clinical Research Med Group
Bellflower, California, United States
Sherif Khamis MD Inc
Canoga Park, California, United States
Advanced Medical Research
Lakewood, California, United States
Madera Family Medical Group
Madera, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
A.G.A Clinical Trials
Hialeah, Florida, United States
Lafayette Clinical Research Group
Lafayette, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
...and 18 more locations