A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) of Phentermine
研究概览
简要总结
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent;
- •Provide written assent (of study subject);
- •Adolescent ≥12 and <18 years of age;
- •Have a BMI ≥ the 95th percentile of BMI for age and gender;
- •Female subjects must be using adequate contraception;
- •Willing and able to comply with all study requirements
排除标准
- •Condition or disease interfering with metabolism;
- •Any medical treatment with insulin;
- •Hyperthyroidism, or clinically significant hypothyroidism;
- •Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
- •Use of chronic systemic glucocorticoid or steroid therapy;
- •History of any eating disorders;
- •Any history of laxative abuse;
- •Prior bariatric surgery;
- •Any history of nephrolithiasis;
- •Any history of epilepsy, or treatment with anti-seizure medications;
- •Positive urine drug screen;
- •Current smoker or smoking cessation within the previous 3 months of screening;
- •Obesity of a known genetic or endocrine origin;
- •Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
- •Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
- •Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
- •Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.
研究组 & 干预措施
Placebo
Days 1-56: Placebo
干预措施: Placebo (Drug)
VI-0521 Mid Dose
- Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
- Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
干预措施: VI-0521 Mid Dose (Drug)
VI-0521 Top Dose
- Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
- Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
- Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
- Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
干预措施: VI-0521 Top Dose (Drug)
结局指标
主要结局
Area Under the Curve (AUC) of Phentermine
时间窗: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Maximum Concentration (Cmax) of Topiramate
时间窗: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Area Under the Curve (AUC) of Topiramate
时间窗: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Apparent Clearance (CL/F) of Phentermine and Topiramate
时间窗: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
时间窗: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Maximum Concentration (Cmax) of Phentermine
时间窗: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
次要结局
- Weight Loss(56 days)
- Change in Blood Pressure(56 days)
- Change in Visual Analog Scale (VAS) Satiety Scores(56 days)
- Change in Lipid Parameters(56 days)
- Change in HOMA-IR(56 days)
- Change in Waist Circumference(56 days)
- Change in OGTT of Fasting and 2-hour Glucose(56 days)
- Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)(56 days)
- Change in Visual Analog Scale (VAS) Hunger Scores(56 days)