Conditions: Influenza
Keywords: Influenza Laninamivir Octanoate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 639
Healthy volunteers: no

Brief summary:
This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

Detailed description:
Approximately 636 subjects will be randomized into the Study.

Following confirmation of circulating influenza in the local area, eligible subjects with recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will be randomized to placebo, 40 or 80 mg of laninamivir octanoate.

The study will be conducted on an outpatient basis. The first dose of study drug will be administered via inhalation within 4 hours of randomization in the clinic, followed by a second dose at home. Participants will be followed for 14 days to assess efficacy, virology and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.

Arms:
arm 1: 40 mg Laninamivir Octanoate and matching placebo arm 2: 80 mg Laninamivir arm 3: Matching Placebo

Interventions: intervention 1: 40 mg Laninamivir Octanoate intervention 2: 80 mg Laninamivir Octanoate intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: