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
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
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.
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: