NCT01472848撤回1 期
A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- - Incidence, severity and duration of nausea and vomiting collected as adverse events.
研究概览
简要总结
This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- •Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis
研究组 & 干预措施
Cohort 1
Experimental
干预措施: PF 05212389 or placebo (Drug)
Cohort 2
Experimental
干预措施: PF 05212389 or placebo (Drug)
Cohort 3
Experimental
干预措施: PF 05212389 or placebo (Drug)
Cohort 4
Experimental
干预措施: PF 05212389 or placebo (Drug)
Cohort 5
Experimental
干预措施: PF 05212389 or placebo (Drug)
Cohort 6
Active Comparator
干预措施: PF 05212389 or placebo (Drug)
结局指标
主要结局
- Incidence, severity and duration of nausea and vomiting collected as adverse events.
时间窗: Day 1 to day 28
次要结局
- - Change in body weight from baseline(Day 1 to day 28)
- - Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline(Day 1 to day 28)
- - Multiple dose PK parameters of PF 05212389(Day 1 to day 28)
- - Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason(Day 1 to day 28)
研究者
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