A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 52
- 试验地点
- 19
- 主要终点
- Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
研究概览
简要总结
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
- •Subject has a documented history of ulcerative colitis for at least 3 months.
- •Subjects who are currently on 5-ASA or product(s) containing or metabolized to mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose of investigational medicinal product.
- •Subjects who are not currently on a drug regimen, or on a 5-ASA or product containing or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks prior to first dose at least 4 weeks prior first dose of investigational medicinal product.
- •Body weight of 18kg-82kg inclusive.
排除标准
- •Current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the IMP, or clinical or laboratory assessments with the exception of their existing ulcerative colitis.
- •Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
- •Any history of hepatic impairment or moderate to severe renal impairment.
- •The use of systemic or rectal steroids within the last 4 weeks, immunomodulators within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7 days prior to the first dose of investigational medicinal product.
研究组 & 干预措施
MMX Mesalamine (100 mg/kg)
干预措施: MMX Mesalamine (Drug)
MMX Mesalamine (60 mg/kg)
干预措施: MMX Mesalamine (Drug)
MMX Mesalamine (30mg/kg)
干预措施: MMX Mesalamine (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
时间窗: Over a 24-hour period starting on day 7
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
时间窗: Over a 24-hour period starting on day 7
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
时间窗: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
时间窗: Over a 24-hour period starting on day 7
Clearance of a substance from the blood by the kidneys.
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
时间窗: Over a 24-hour period starting on day 7
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
时间窗: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
时间窗: Over a 24-hour period starting on day 7
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
时间窗: Over a 24-hour period starting on day 7
次要结局
- Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State(Over a 24-hour period starting on day 7)
- Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State(Over a 24-hour period starting on day 7)
- Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State(Over a 24-hour period starting on day 7)