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

Fecha de inicio: 1 de mayo de 2013

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 Hepatitis B, C, & HIV Negative Surgically sterile or ≥ 12 months post-menopausal Non-pregnant females 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