NCT02818543已完成1 期
An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Lycera Corp.
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Time to maximum observed plasma concentration (Tmax)
研究概览
简要总结
The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active ulcerative colitis defined as a Mayo endoscopy score of ≥ 2 despite therapy.
- •Male or female age 18 to 75
- •May be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy
排除标准
- •Current anti-tumor necrosis factor use
- •Current immunosuppressant use (Note: this does not include corticosteroid use)
- •Subjects with only distal active disease (i.e. proctitis)
- •Clinically significant active infection
- •Known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required
- •History of malignancy within the last 5 years except non-melanoma skin cancer or cervical carcinoma in situ
- •Clinically significant lab abnormalities (i.e. liver function abnormalities, renal insufficiency, abnormal absolute neutrophil count or hemoglobin)
- •History of colon resection
- •Any other investigational therapy or investigational biologics use within 8 weeks of investigational medicinal product administration
研究组 & 干预措施
Cohort 1
Experimental
LYC-30937 25 mg single oral dose
干预措施: LYC-30937 (Drug)
Cohort 2
Experimental
LYC-30937 100 mg single oral dose
干预措施: LYC-30937 (Drug)
结局指标
主要结局
Time to maximum observed plasma concentration (Tmax)
时间窗: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Maximum observed plasma concentration (Cmax)
时间窗: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose
Percentage of estimated Area Under the Curve (0-inf)
时间窗: up to 48 hours
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
次要结局
- Treatment emergent adverse events (TEAEs)(7 days post-dose)
- Vital signs(7 days post-dose)
- 12-Lead Electrocardiogram (ECG)(7 days post-dose)
- Clinical laboratory data(7 days post-dose)
研究者
研究点 (2)
Loading locations...
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