NCT02989168终止2 期
A Phase II Open Label Study to Evaluate the Effect of GBT440 on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Who Are Using Supplemental Oxygen at Rest (ZEPHYR)
Global Blood Therapeutics0 个研究点目标入组 14 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 主要终点
- Change in Oxygen Saturation at End of Treatment Period Compared to Baseline
研究概览
简要总结
This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of IPF.
- •Receiving supplemental oxygen for use at rest.
- •Weight ≥ 40 kg.
- •Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug.
排除标准
- •FEV1/FVC < 70%
- •History of other interstitial lung diseases.
- •Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening.
- •Corticosteroid (> 10 mg per day of prednisone or an equivalent) administered for 7 days or longer, within 30 days of screening.
- •Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
- •Female who is breast-feeding or pregnant
- •Current smoker or history of smoking within 3 months from screening
研究组 & 干预措施
GBT440 900 mg Dose
Experimental
Part A, 900 mg
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
干预措施: GBT440 (Drug)
GBT440 1500 mg Dose
Experimental
Part B , 1500 mg
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
干预措施: GBT440 (Drug)
结局指标
主要结局
Change in Oxygen Saturation at End of Treatment Period Compared to Baseline
时间窗: Days 1 to 90
次要结局
- Evaluate the Effect of GBT440 on Performance of the 6MWT(Days 1 to 90)
- Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin))(Day 1 (15 mins post-dose and 2-4h post-dose), Day 15 (pre-dose), Day 30 (pre-dose), Day 60 (pre-dose and 2-4h post-dose), Day 90 (pre-dose), Day 105 (during study visit), and Day 120 (during study visit))
- Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes(Days 1 to 90)
- Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline(Days 1 to 90)
- Evaluate the Effect of GBT440 on Resting and Post-exercise Alveolar-arterial O2 Tension Difference [P(A-a) O2] at End of Treatment Period Compared to Baseline(Days 1 to 90)
- Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco)(Days 1 to 90)
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0(Days 1 to 90)
研究者
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