NCT02846324已完成2 期
A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Global Blood Therapeutics0 个研究点目标入组 39 人开始时间: 2016年6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
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of IPF.
- •Oxygen desaturation with exercise.
- •Completion of the baseline 6MWT
- •Weight ≥ 50 kg
- •Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.
排除标准
- •FEV1/FVC < 70%.
- •Subjects on supplemental oxygen therapy at rest.
- •History of other interstitial lung diseases.
- •Significant polycythemia.
- •Female who is breast-feeding or pregnant.
- •Known current malignancy or history of malignancy within the last 2 years prior to screening.
- •Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
- •Hospitalization due to an exacerbation of IPF within 30 days of screening
- •Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening
- •Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of screening.
- •Current smoker or history of smoking within 3 months of screening.
- •Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
- •History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
- •Any condition possibly affecting drug absorption.
- •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).
- •Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.
研究组 & 干预措施
GBT440 600 mg Dose
Experimental
Parts A and B
干预措施: GBT440 (Drug)
GBT440 900 mg Dose
Experimental
Part A
干预措施: GBT440 (Drug)
GBT440 1500 mg Dose
Experimental
Part B
干预措施: GBT440 (Drug)
Placebo
Placebo Comparator
Parts A and B
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
时间窗: Days 1 to 58
次要结局
- Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life(Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only)
- Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise(Baseline to Day 28)
- Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest(Baseline to Day 28)
- Pharmacokinetic Profile of GBT440 Including Maximum Concentration(Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only)
- Pharmacokinetic Profile of GBT440 Including Minimum Concentration(Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only)
研究者
相似试验
招募中
2 期
Study of Stapokibart Injection in Patients With Allergic RhinitisAllergic RhinitisNCT06525597Keymed Biosciences Co.Ltd120
已完成
2 期
A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 VaccineCOVID-19 PandemicNCT05652543Sinocelltech Ltd.518
已完成
2 期
Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee OsteoarthritisOsteoarthritis of KneeNCT04506463Sun Pharmaceutical Industries Limited397
已完成
2 期
A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary Fibrosis (IPF)NCT03832946Galecto Biotech AB172
已完成
1 期
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 YearsCOVID-19NCT04470609Institute of Medical Biology, Chinese Academy of Medical Sciences471