Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza

BioCryst Pharmaceuticals74 enrolled

Overview

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of 600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza infection and in subjects with acute uncomplicated influenza infection at higher risk for influenza complications. All subjects will receive IV peramivir.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Influenza

Interventions

PeramivirDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at least one clinical sign or symptom consistent with acute influenza infection as listed below OR * Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least moderate severity (cough or rhinitis) and at least one constitutional symptom of at least moderate severity (myalgia \[aches and pains\], headache, feverishness, or fatigue) * Influenza symptom onset \< 48 hours. However, due to historically delayed presentation for medical care in the adult population, approximately 20% of the elderly population may be enrolled with symptoms starting \> 48-hours but ≤ 72-hours Exclusion Criteria: * Women who plan to breast-feed for the first 48 hours after study drug administration * Subjects requiring hospital admission to treat medical condition(s) which could represent complications of influenza. * Recent worsening of any chronic medical condition consistent with complications of influenza * Current evidence of a bacterial infection requiring antibiotic treatment

Locations (15)

Peramivir Investigational Site

Brooksville, Florida, United States

Peramivir Investigational Site

Lakeland, Florida, United States

Peramivir Investigational Site

Outcomes

Primary Outcomes

Safety and Tolerability, as Measured by the Number of Adverse Events.

Safety was evaluated through assessment of Adverse Events (AEs).

Time frame: 14 days

Secondary Outcomes

Plasma Exposure of IV Peramivir as Measured by Drug Concentrations up to 3 Hours Post Infusion

Up to 3 plasma samples will be drawn, where possible: immediately following infusion, 30 mins to 1 hr post-infusion \& 1 to 3 hrs post-infusion. Maximum concentration (Cmax), area under the concentration vs. time curve (AUC) from time 0 to 1 hour (AUC0-1), AUC from time 0 to 1.5 hours (AUC0-1.5), and AUC from time 0 to the last measurable time point (AUC0-last) were calculated in Phoenix® WinNonlin® v6.4. No summary statistics were reported due to the variation in the infusion time and sampling times.

Time frame: up to 3 hours post peramivir infusion

Time to Resolution of Fever

Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had an oral temperature \< 37.4°C/99.4°F oral and no antipyretic medications were taken for at least 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data. Subjects who did not have resolution of fever were censored at the time of their last non-missing post-baseline temperature assessment.

Time frame: 14 days

Time to Resolution of Influenza Symptoms

Subjects were asked to provide an assessment of 7 influenza symptoms (cough, sore throat, nasal congestion, myalgia \[aches and pains\], headache, feverishness, and fatigue) on a 4-point severity scale (0, absent; 1, mild; 2, moderate; 3, severe) beginning at Screening then twice daily beginning on Day 1 through to Day 13, and prior to the subject's clinic visit on Day 14. Once all symptoms were scored a 0 or 1 for at least 48 hours, recordings were discontinued. The time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 21.5-hour period (24 hours less 10%), where all symptoms of influenza were recorded as none (0) or mild (1), was estimated overall and for each age group using the Kaplan-Meier method.

Data from ClinicalTrials.gov

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