A Phase 1, Randomized, 2-way Crossover, Food-effect Study of Ecopipam Pharmacokinetics After Administration of the to Be Marketed Tablet in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Cmax of ecopipam after administration of an ecopipam tablet in the fed state
研究概览
简要总结
Standard food-effect study to identify the effect of food on ecopipam pharmacokinetics after administration of a to-be-marketed ecopipam tablet in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Male subjects or female subjects of non-childbearing potential
- •≥18 and ≤55 years of age
- •BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- •Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, vital signs, and standard panel of blood and laboratory tests at Screening.
- •Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug.
- •Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
排除标准
- •History of significant medical illness
- •Clinically significant abnormalities on screening tests/exams
- •History of or significant risk of committing suicide
- •Donation of plasma within 1 month prior to dosing
- •Donation or significant loss of blood within 8 weeks prior to the first dosing
- •Major surgery within 3 months or minor surgery within 1 month prior to admission
- •Use of prohibited prescription, over-the-counter medications or natural health products
- •Use of tobacco or nicotine products within 1 month prior to Screening
- •Significant alcohol consumption or history of abuse
- •History of drug abuse within the previous 2 years, or a positive drug screen
- •History of cannabinoid use within the previous 3 months
- •Positive urine drug screen, urine cotinine test, or alcohol breath test
- •History of allergy to study medications
- •Recent participation in a clinical research study
- •Prior exposure to ecopipam
- •Not suitable for study in the opinion of the Principal Investigator
研究组 & 干预措施
Dosed in fasted state
Ecopipam will be taken in the morning in a fasted state
干预措施: Ecopipam tablet (Drug)
Dosed in fed state
Ecopipam will be taken in the morning after a standard high-fat breakfast
干预措施: Ecopipam tablet (Drug)
结局指标
主要结局
Cmax of ecopipam after administration of an ecopipam tablet in the fed state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Tmax of ecopipam after administration of an ecopipam tablet in the fed state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC of ecopipam after administration of an ecopipam tablet in the fed state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam after administration of an ecopipam tablet in the fed state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of ecopipam after administration of an ecopipam tablet in the fed state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam after administration of an ecopipam tablet in the fasted state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
Tmax of ecopipam after administration of an ecopipam tablet in the fasted state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUC of ecopipam after administration of an ecopipam tablet in the fasted state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of ecopipam after administration of an ecopipam tablet in the fasted state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam after administration of an ecopipam tablet in the fasted state
时间窗: Up to Day 13
Up to 36 samples will be collected at the indicated time points for pharmacokinetic analysis
次要结局
- Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fed state(Up to Day 13)
- AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fed state(Up to Day 13)
- AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Cmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- Tmax of EBS-101-40853 after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUClast of EBS-101-40853 after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUCinf of EBS-101-40853 after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Cmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- Tmax of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- AUClast of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Tmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUCinf of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fed state(Up to Day 13)
- Cmax of EBS-101-40853 glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUClast of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- AUCinf of ecopipam glucuronide after administration of an ecopipam tablet in the fasted state(Up to Day 13)
- Safety and tolerability as demonstrated by concomitant medications(Up to Day 20)
- Safety and tolerability as demonstrated by physical exams(Up to Day 20)
- Safety and tolerability as demonstrated by AEs(Up to Day 20)
- Systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)(Up to Day 20)
- Respiratory rate (breaths/minute)(Up to Day 20)
- Oral temperature (degrees Celsius)(Up to Day 20)
- Electrocardiogram (ECG) parameters: HR, PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)(Up to Day 20)
- Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)(Up to Day 20)
- Value of hematocrit (percent)(Up to Day 20)
- Value of hemoglobin (g/dL)(Up to Day 20)
- Red blood cell (RBC) count (M/mm3)(Up to Day 20)
- Values of bicarbonate, sodium, magnesium, potassium, chloride (mmol/L)(Up to Day 20)
- Values of urea, phosphorus, calcium, glucose, total cholesterol, HDL, LDL, triglycerides, uric acid, and total, direct and indirect bilirubin (mg/dL)(Up to Day 20)
- Values of albumin and total protein (g/dL)(Up to Day 20)
- Values of amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), creatine phosphokinase (CPK), and creatinine (U/L)(Up to Day 20)
- Value of urine pH(Up to Day 20)
- Value of urine glucose(Up to Day 20)
- Value of urine protein(Up to Day 20)
- Value of urine blood(Up to Day 20)
- Value of urine leukocyte esterase by dipstick(Up to Day 20)