NCT01203943终止2 期
A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF)
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
- Celgene
- 入组人数
- 28
- 试验地点
- 22
- 主要终点
- Safety
研究概览
简要总结
The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of non-childbearing potential ≥50 years of age (at the time of signing the informed consent document) with documented IPF
- •Diagnosis of IPF based on current ATS/ERS guidelines
- •Usual interstitial pneumonia (UIP) pattern on HRCT and/or UIP pattern on histopathology (ie surgical lung biopsy), and
- •Exclusion of known causes of interstitial lung disease (such as environmental exposure, connective tissue disease and drug toxicity), Or
- •UIP pattern on surgical lung biopsy required if HRCT is inconsistent with UIP
排除标准
- •FVC : < 50% predicted >90% predicted
- •DLco:< 25% predicted >90% predicted
- •Saturated oxygen (SpO2) of <92% (room air [sea level] at rest). SpO2 of < 88% (room air [≥ 5,000 feet above sea level (1524 meters]) at rest)
- •Use of any cytotoxic/immunosuppressive agent (other than prednisone ≤ 12.5 mg/day or equivalent) including, but not limited to, azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks of screening
- •Use of any cytokine modulators:
- •Use of any biologic agent (such as etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab) within 12 weeks or five half-lives of screening, and in the case of rituximab, use within 24 weeks of screening or no recovery of CD 19-positive B lymphocytes if the last dose of rituximab has been more than 24 weeks prior to screening
- •Alefacept within 24 months of randomization
- •Use of any therapy targeted to treat IPF (including but not limited to d-penicillamine, endothelium receptor antagonist [eg bosentan, ambrisentan], interferon gamma-1B, pirfenidone) within 4 weeks of screening
- •Use of n-acetylcysteine (NAC) for IPF (≥1800 mg/day) within 4 weeks of screening
- •Use of any investigational drug within one month of screening, or 5 PD/PK half lives, if known (whichever is longer)
- •Current smoker
研究组 & 干预措施
Cohort 2
Experimental
• Cohort 2: CC-930 100 mg PO daily (one 100 mg capsule once per day PO) beginning on Day 1 in the AM
干预措施: CC-930 (Drug)
Cohort 1
Experimental
• Cohort 1: CC-930 50 mg PO daily (two 25 mg capsules once per day PO) beginning on Day 1 in the AM.
干预措施: CC-930 (Drug)
Cohort 3
Experimental
• Cohort 3: CC-930 100 mg twice daily approximately 12 hours apart (one 100 mg capsule twice per day PO) beginning on Day 1.
干预措施: CC-930 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety
时间窗: Week 4
Number of participants with adverse events
次要结局
- Pharmacokinetics-Vz/f(Week 0 (baseline) and week 2)
- Pharmacokinetics-CL/F(Week 0 (baseline) and week 2)
- Long-term safety(Weeks 52-104)
- Disease progression/death rates(Weeks 52-104)
- Pharmacokinetics-Cmax(Week 1 (baseline) and week 2)
- Pharmacokinetics-Cmin(Week 0 (baseline) and week 2)
- Pharmacokinetics-AUC(Week 0 (baseline) and week 2)
- Pharmacokinetics-Tmax(Week 0 (baseline) and week 2)
- Pharmacokinetics - t 1/2(Week 0 (baseline) and week 2)
研究者
研究点 (22)
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