Status:
COMPLETED
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF
Lead Sponsor:
Gilead Sciences
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01840735
Start Date
May 1 2013
End Date
August 1 2013
Last Update
August 12 2014
Active Locations (1)
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1
Compass Research Phase 1, LLC
Orlando, Florida, United States, 32806