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The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects

NCT01494636 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-06-20

No results posted yet for this study

Summary

This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The study is split into two parts. Part A will assess the safety and tolerability of the new drug. Part B will assess safety and tolerability as well as the effect of GSK2339345 on induced cough.

Conditions

Interventions

DRUG

GSK2339345 (solution)

3, 6, 15, 30, 60 and 120 micrograms (proposed doses). 2 alternating cohorts of 6 subjects. Each subject to receive 3 ascending doses with washout of at least 48 hours between doses. Rinse, Gargle and Spit.

DRUG

GSK2339345 (nebulised)

25, 100, 250, 1000 and 2000 micrograms (proposed doses). Subjects randomised to receive three ascending doses (with each dose given on two consecutive days). Washout of at least 6 days between treatment periods. Nebulised.

DRUG

Placebo (0.9% sodium chloride solution)

Administered on Day 1 of one of the treatment periods in part B. Randomised. Nebulised.

DRUG

Lidocaine

40mg dose. Administered on Day 2 of one of the treatment periods in part B. Randomised. Nebulised.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-17
Primary Completion
2012-03-15
Completion
2012-03-15

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 NCT01494636 on ClinicalTrials.gov