A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-5737 in Subjects With Cystic Fibrosis

Gilead Sciences1 site in 1 country8 target enrollmentMay 2013

ConditionsCystic Fibrosis

InterventionsGS-5737 Placebo

DrugsGS-5737 Placebo

Overview

Phase: Phase 1
Intervention: GS-5737
Conditions: Cystic Fibrosis
Sponsor: Gilead Sciences
Enrollment: 8
Locations: 1
Primary Endpoint: Peak Plasma Concentration (Cmax) of GS-5737
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

August 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females, ≥ 18 years of age, at Screening
•Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria, with at least 1 of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR Abnormal nasal transepithelial potential difference (NPD) test OR Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND 1 or more accompanying clinical features consistent with CF
•FEV1 ≥ 40% and ≤ 90% predicted
•BMI ≥ 19 and ≤ 30 kg/m2
•Clinically stable with no evidence of significant new or acute respiratory symptoms
•Chest radiograph without significant acute findings; or chest radiograph, CT, or MRI obtained and interpreted within 90 days prior to enrollment, without acute findings and no significant intercurrent illness; chronic, stable findings are allowed
•History of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year =
•1 pack-year) and non-smokers of at least 60 days duration prior to Screening
•Estimated creatinine clearance ≥ 80 mL/min at Screening
•Negative drug tests; including alcohol

Exclusion Criteria

•Experienced symptoms of recent acute upper or lower respiratory tract infection or acute pulmonary exacerbation requiring treatment within 2 weeks prior to Screening
•Plasma potassium ≥ 5 mEq/L
•Changes in chronic azithromycin use, bronchodilator (BD), dornase alfa, HS, physiotherapy technique or regimen, antibiotics or corticosteroid medications within 28 days prior to Screening
•History of sputum or throat swab culture yielding Burkholderia species within 2 years of Screening