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

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

October 17, 2011

Primary Completion Date

March 15, 2012

Study Completion Date

March 15, 2012

Conditions
Cough
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.

Trial Locations (1)

M23 9QZ

GSK Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01494636 - The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects | Biotech Hunter | Biotech Hunter