A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers
NCT00999531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2010-03-10
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.
Conditions
- Cystic Fibrosis
- Mucociliary Clearance
- Airway Hydration
Interventions
- DRUG
-
GS-9411
Inhaled GS-9411 dissolved in sterile saline
- DRUG
-
Inhaled Placebo, sterile saline
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Peter Hodsman, MD · Nucleus Network Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-03-31
Countries
- Australia
Study Locations
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