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

Gilead Sciences1 site in 1 country15 target enrollmentSeptember 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: 15
Locations: 1
Primary Endpoint: Safety and Tolerability of 4 escalating doses of GS-9411 in healthy male 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 escalating doses of GS-9411 in healthy male 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 4 dose levels of GS-9411 as an inhaled product, compared to a matched placebo.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

September 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Gilead Sciences

Eligibility Criteria

Inclusion Criteria

•Males 18 to 45 years of age
•No clinically important abnormal physical findings at the screening examination
•No clinically relevant abnormalities in the results of laboratory screening evaluation
•Normal (or abnormal but not clinically significant) ECG
•Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate(HR).
•Body weight between 70 and 125 kg and body mass index (BMI) between 18 and 28 kg/m
•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.
•Non-smokers of at least 6 months duration (\< 10 pack/year history) prior to study entry.
•Negative for drugs of abuse (including alcohol) at Screening and Day -

Exclusion Criteria

•Any prior exposure to GS-
•Administration of any investigational drug in the period 0 to 12 weeks before entry to the study.
•A need for any medication during the period 0 to 5 days before entry to the study, 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 the previous 2 months.
•Donation or loss of greater than 400 mL of blood in the period 0 to 12 weeks before entry to the study.
•Serious adverse reaction or hypersensitivity to any drug.
•Presence or history of any pulmonary diseases (e.g., asthma, emphysema, chronic bronchitis, cystic fibrosis, bronchiectasis).
•Consumption of drugs and/or herbal preparations capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) or enzyme-inhibiting agents (e.g., cimetidine) or similar drugs within 30 days (or 5 half-lives of inducing/inhibiting agent, whichever is longer) of enrollment in this study.
•Major surgery within 6 months of the start of this study.