NCT00964912已完成1 期
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2008年7月最近更新:
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
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of BMS-820836 following single-dose administration
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
- •Right-handed, non-ambidextrous subjects for Part 2
- •Men and women, ages 18 to 55 years, inclusive
排除标准
- •Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- •WOCBP using a prohibited contraceptive method
- •Women who are pregnant or breastfeeding
- •Sexually active fertile men not using effective birth control if their partners are WOCBP
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months) gastrointestinal disease
- •History of cholecystectomy
- •Any major surgery within 4 weeks of study drug administration
- •Any gastrointestinal surgery that could impact the absorption of study drug
- •Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
- •Blood transfusion within 4 weeks of study drug administration
- •Inability to tolerate/swallow oral medication
- •Difficulty with venipuncture and/or poor venous access
- •Self-reported smokers
- •Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
- •Confirmed resting supine systolic blood pressure > 130 mmHg
- •Confirmed resting supine diastolic blood pressure > 80 mmHg
- •Confirmed QT value ≥ 500 msec
- •Confirmed QTc (Bazett) value ≥ 450 msec
- •History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- •History of peppermint allergies
- •History of brain conditions (e.g. history of stroke, head trauma, etc.)
- •History of or current psychiatric conditions
- •History of claustrophobia
研究组 & 干预措施
BMS-820836 (Part 1, Panel 1)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 1)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 2)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 2)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 3)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 3)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 4)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 4)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 5)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 5)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 6)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 6)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 7)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 7)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 8)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 8)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 1, Panel 9)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 1, Panel 9)
Active Comparator
干预措施: Placebo (Drug)
BMS-820836 (Part 2, Panel A)
Active Comparator
干预措施: BMS-820836 (Drug)
BMS-820836 (Part 2, Panel B)
Active Comparator
干预措施: BMS-820836 (Drug)
结局指标
主要结局
To assess the safety and tolerability of BMS-820836 following single-dose administration
时间窗: Within 14 days of first dose
次要结局
- To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007(Within 7 days of dosing)
- To assess the pharmacodynamics of BMS-820836(Within 48 hours of dosing)
研究者
研究点 (1)
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