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

NCT01587716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-07-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GSK2339345 (Inhaled) Single Dose

250, 1000 and 2000 microgram (proposed doses)

OTHER

Placebo (Inhaled) Single Dose

Inhaled 0.9% sodium chloride solution

DRUG

GSK2339345 (Inhaled) Repeat Dose

2000 microgram (proposed dose) administered 4 times a day for two consecutive days

OTHER

Placebo (Inhaled) Repeat Dose

Inhaled 0.9% sodium cholride solution

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-23
Primary Completion
2012-07-30
Completion
2012-07-30

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 NCT01587716 on ClinicalTrials.gov