NCT03414788撤回1 期
PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 2
- 主要终点
- Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
研究概览
简要总结
The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis or Crohn's Disease. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent
- •Only women of non-child bearing potential
- •Diagnosis of active UC (histologic) or CD prior to study entry for a minimum of 4 months
- •Subjects with moderate to severe, active UC as defined by Mayo endoscopic index of at least 2; or subjects with moderate to severe, active CD as defined by SES-CD score of at least 7.
排除标准
- •Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)
- •Active enteric infections
- •Other forms of colitis such as infectious colitis etc
结局指标
主要结局
Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma
时间窗: 24 hours
Treatment Arm
Standardized uptake value (SUV) in the colon (inflamed and non inflamed)
时间窗: 24 hours
Treatment Arm
次要结局
- AUC of PF 06687234 plasma concentrations over time(42 days)
- AUC of plasma radioactivity concentration (% ID/kg)(24 hours)
- AUC in plasma, colon, liver, spleen, kidney and small intestine(24 hours)
- Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma(24 hours)
- Frequency of clinically relevant abnormalities for Safety Labs(42 days)
- Cmax of PF 06687234 plasma concentrations over time(42 days)
- Tmax of PF 06687234 plasma concentrations over time(42 days)
- Cmax of plasma radioactivity concentration (% ID/kg)(24 hours)
- Tmax of plasma radioactivity concentration (% ID/kg)(24 hours)
- Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine(24 hours)
- Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine(24 hours)
- Frequency of clinically relevant abnormalities for vital signs(42 days)
- Frequency of clinically relevant abnormalities for ECG(42 days)
- Frequency of clinically relevant abnormalities for Immunogenicity(42 days)
研究者
研究点 (2)
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