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

Gilead Sciences1 site in 1 country24 target enrollmentOctober 2009

ConditionsCystic Fibrosis Mucociliary Clearance Airway Hydration

InterventionsGS-9411 Placebo

DrugsGS-9411 Placebo

Overview

Phase: Phase 1
Intervention: GS-9411
Conditions: Cystic Fibrosis
Sponsor: Gilead Sciences
Enrollment: 24
Locations: 1
Primary Endpoint: Safety and tolerability of multiple doses of inhaled GS-9411 in healthy volunteers
Status: Completed
Last Updated: 16 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 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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gilead Sciences

Eligibility Criteria

Inclusion Criteria

•Males and females, 18 to 65 years of age
•No clinically important abnormal physical findings at Screening
•No clinically relevant abnormalities in the results of laboratory evaluation at Screening
•Must test negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) at Screening
•Normal electrocardiogram (ECG) at Screening
•Normal blood pressure (BP) and heart rate (HR) in the absence of any medications for body weight between 50 and 125 kg and within ± 15% of ideal body weight or body mass index (BMI) between 18 and 28 kg/m2 at Screening
•Able to communicate well with the investigator and to comply with the requirements of the entire study
•Provision of written informed consent to participate as shown by a signature on the volunteer consent form
•Nonsmokers of at least 180 days (6 months) duration (\< 10 pack/year history) prior to Screening
•Negative for drugs of abuse (including alcohol) at Screening and Day -5

Exclusion Criteria

•Any prior exposure to GS-9411
•Administration of any investigational drug in the period 84 days (12 weeks) prior to Screening; 112 days (16 weeks) if the previous investigational drug was a new chemical entity
•A need for any medication during the period 0 to 5 days prior to Screening, except those deemed by the principal investigator/clinical investigator not to interfere with the outcome of the study
•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
•Presence or history of allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within 56 days (8 weeks) of Screening
•Donation or loss of greater than 400 mL of blood in the period 84 days (12 weeks) prior to Screening
•Serious adverse reaction or hypersensitivity to any drug
•Presence or history of any pulmonary diseases (e.g., asthma, emphysema, chronic bronchitis, CF, bronchiectasis)
•Lactating females
•History of glaucoma