A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF)

Gilead Sciences1 site in 1 countryDecember 2009

ConditionsCystic Fibrosis Mucociliary Clearance

InterventionsGS-9411 Placebo

DrugsGS-9411 Placebo

Overview

Phase: Phase 1
Intervention: GS-9411
Conditions: Cystic Fibrosis
Sponsor: Gilead Sciences
Locations: 1
Primary Endpoint: To evaluate the safety and tolerability of escalating doses of inhaled GS-9411 in subjects with CF.
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of GS-9411 in patients with Cystic Fibrosis. 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 2 dose levels of GS-9411 as an inhaled product, compared to a matched placebo.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

April 2010

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females aged 18 to 65 years
•Patients with diagnosis of CF as confirmed by at least one of the following:
•Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
•Documented sweat sodium test ≥ 60 mmol/L OR
•Abnormal nasal potential difference test OR
•At least one well-characterized disease-causing genetic mutation in the CF transmembrane conductance regulatory (CFTR) gene AND
•Accompanying symptoms characteristic of CF
•Normal (or abnormal but not clinically significant) electrocardiogram (ECG)
•Normal intraocular pressure (IOP) between 10 and 21 mm Hg at Screening.
•Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate (HR) in the absence of any medications for hypertension; these will be measured after the subject has rested supine for 3 minutes; normal BP is taken to be 90 to 140 mm Hg systolic and 50 to 89 mm Hg diastolic; normal HR is taken to be 40 to 100 beats per minute (bpm)

Exclusion Criteria

•Administration of any investigational drug or device in the 28 days prior to Screening
•A need for any new medication during the period 28 days before first dosing with study drug, except those deemed by the principal investigator/clinical investigator not to interfere with the outcome of the study
•Subjects who routinely use inhaled hypertonic saline must discontinue use for at least 14 days prior to clinic admission and for the duration of the study
•Use of trimethoprim or high dose ibuprofen (\> 800 mg/day) during the 28 days prior to first dosing
•Serious adverse reaction or hypersensitivity to any drug
•Existence of any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug
•Lactating females
•History of airway intolerance to hypertonic saline
•History of lung transplantation
•History of a positive test for Burkholderia cepacia