Cough Clinical Trial - A Study to Investigate the Safety, Tolerability &

Status Completed

Clinical Trial Summary

This is a study of the sodium channel inhibitor, GSK2339345. Cohort 1 will assess the safety, tolerability and PK of single ascending doses of GSK2339345 administered via an aqueous droplet inhaler in healthy subjects. Cohort 2 will assess the safety, tolerability, and PK of repeat doses of GSK2339345 administered four times a day for two consecutive days via an aqueous droplet inhaler.

Clinical Trial Description

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) effects of GSK2339345 in healthy subjects. GSK2339345 is a blocker of neuronal voltage gated sodium channels in development for the treatment of chronic cough, excessive cough and post-viral and viral (acute) cough. Inhaled pan NaV inhibitors are associated with oropharyngeal sensation perturbation and so this study will establish the potential local sensate effects of GSK2339345 at multiples of the predicted inhaled therapeutic dose. This study also aims to define the maximum tolerated dose of GSK2339345 administered via an aqueous droplet inhaler. Cohort 1 is a randomised, double-blind, placebo-controlled, cross-over, inhaled single-dose escalating study using an aqueous droplet inhaler. Cohort 1 will include assessments of sensate changes via a 4 point scale, assessment of taste via an 11 point scale, and PK assessments to investigate the PK profile of GSK2339345. Cohort 2 of this study is a randomised, double blind, placebo controlled, parallel group, inhaled repeat dose study using a aqueous droplet inhaler. Subjects will be randomised to receive 2000 microgram of GSK2339345 or placebo four times a day for two consecutive study days. Similar assessments of sensations to those used in Cohort 1 will be performed. The potential for systemic cardiovascular (CV) or central nervous system (CNS) effects will also be assessed throughout the study via observation. Cohort 2 will also include PK assessments to investigate the PK profile of GSK2339345. Placebo will be used throughout the study as a control. ;

Study Design

Related Conditions & MeSH terms

Cough

Clinical Trial Details

NCT number	NCT01587716
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	April 23, 2012
Completion date	July 30, 2012

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2339345.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms