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

NCT02022761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-05-30

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Jolanta Airey, Dr · Biota Scientific Management Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-10-31
Completion
2014-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02022761 on ClinicalTrials.gov