NCT02022761

Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate in Adults With Chronic Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Biota Scientific Management Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre, randomized, double-blind, placebo-controlled, single ascending dose study, in which the safety and pharmacokinetics of laninamivir octanoate administered by inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic asthma.

Detailed description

32 subjects, as two sequential groups of 16 subjects at each dose level (40 mg and 80 mg), will be randomised 3:1 to receive active drug or matching placebo. Males and females aged 18 to 65 years inclusive, with mild or moderate chronic asthma. Stratum 1: Mild asthma - requiring treatment consistent with Global Initiative for Asthma (GINA) Step 2 Stratum 2: Moderate asthma - requiring treatment consistent with GINA Step 3 Following a screening period of up to 30 days, eligible consenting subjects will be admitted to the clinic on the morning of Day 1. Laninamivir octanoate will be administered on Day 1. Subjects will remain in the clinic until Day 3 and will return for subsequent outpatient visits on Day 5, Day 6 and Day 7. A final follow-up visit for safety evaluations will occur on Day 14 ± 1 (or at the time of premature discontinuation). Each subject will participate in the study for approximately 7 weeks.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Laninamivir octanoate	40 mg dose consists of 2 laninamivir octanoate TwinCaps® DPI 80 mg dose consists of 4 laninamivir octanoate TwinCaps® DPI (2 administered 12 hours apart)

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-10-01
• Completion: 2014-02-01
• First posted: 2013-12-30
• Last updated: 2018-05-30

Locations

1 site across 1 country: United Kingdom