NCT01840735已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of GS-5737
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GS-5737
Active Comparator
The GS-5737 85 μg dose is contained in 4 mL of 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline.
干预措施: GS-5737 (Drug)
Placebo
Placebo Comparator
The vehicle (placebo) control contains 10 mM citrate buffer, pH 5.0 in 2.8% (w/v) saline in 4 mL.
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of GS-5737
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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