NCT02022956已完成1 期
An Open-label, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetic Properties of BELVIQ in Obese Adolescent Subjects Ages 12-17 (Inclusive)
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
- Eisai Inc.
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)
研究概览
简要总结
The purpose of this study is to evaluate the PK properties, tolerability, and safety of lorcaserin HCL (BELVIQ) in obese adolescent subjects between the ages of 12 to 17 years old
详细描述
The purpose is to:
- Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)
- Assess the safety and tolerability of a single oral dose of lorcaserin in obese adolescent subjects ages 12-17 (inclusive)
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent subjects aged 12 to 17 years, inclusive at screening
- •a. Eligible female subjects who are sexually active will be:
- •non-pregnant
- •non-lactating
- •agree to continue to use an accepted method of birth control for at least 1 month after study medication administration
- •BMI ≥ 95th percentile for age and gender, but ≤ 44 kg/m21
- •Considered to be in stable health in the opinion of the Investigator.
- •Parent or guardian who can sign written informed consent and subject willing to sign assent
排除标准
- •Clinically significant new illness in the 1 month before screening and any time prior to randomization
- •Significant renal or hepatic disease
- •Secondary (chromosomal, endocrine, or metabolic) causes of obesity
- •Use of medications other than hormonal contraceptives and acetaminophen
- •Use of drugs with serotonergic activity within 1 month before screening
- •Recent treatment with over-the-counter weight loss products or appetite suppressants, or within 3 months of screening and any time prior to randomization with a prescription weight loss drug or lipid dissolving injections or ongoing psychotherapy for weight loss outside of this trial
- •Recent history of alcohol, tobacco, or recreational drug/solvent use
- •Any history of major depression, anxiety, bipolar disorder, schizophrenia, or Axis II psychiatric disease requiring treatment with prescription medication within six months prior to screening
研究组 & 干预措施
Open-Label Lorcaserin (BELVIQ)
Experimental
干预措施: Lorcaserin (Drug)
结局指标
主要结局
Assess the single-dose pharmacokinetic (PK) parameters of lorcaserin and a primary metabolites (M1 and M5) in obese adolescent subjects ages 12-17 (inclusive)
时间窗: 45 min pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (2)
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