NCT00999531

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of repeated doses of GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.

Detailed description

GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary clearance in patients with cystic fibrosis. This study is evaluating the safety and tolerability of 3 dose levels of GS-9411 as an inhaled product, compared to a matched placebo, administered twice daily for 14 days.

Conditions

• Cystic Fibrosis
• Mucociliary Clearance
• Airway Hydration

Interventions

Type	Name	Description
DRUG	GS-9411	Inhaled GS-9411 dissolved in sterile saline
DRUG	Placebo	Inhaled Placebo, sterile saline

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2009-10-21
• Last updated: 2010-03-10

Locations

1 site across 1 country: Australia