NCT03583489已完成1 期
A Randomised, Double-blind, Placebo-controlled, Crossover Study in Healthy Adult Subjects to Investigate the Effect of Intravenous APD421, With and Without Ondansetron, on Cardiac Conduction
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ddQTcF
研究概览
简要总结
Collection of pharmacokinetic and electrocardiograph data from healthy volunteers given APD421 +/- ondansetron
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Age 18 to 65 years of age at time of signing ICF
- •Body mass index (BMI) of 18 to 30 kg/m2
- •Must be willing and able to communicate and participate in the whole study
- •Must provide written informed consent
- •Must agree to use an adequate method of contraception
排除标准
- •Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the 3 months prior to IMP administration on this study
- •Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •Subjects who have previously been enrolled in this study
- •Women who are pregnant or breastfeeding
- •Subjects who have received amisulpride for any indication within the previous 4 weeks
- •Allergy to amisulpride or any of the excipients of APD421 or ondansetron
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption >21 units per week
- •Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products (current smoking may be assessed by a validated technique such as urine or serum cotinine levels)
- •Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- •History of epilepsy
- •History of clinically significant syncope
- •Family history of sudden death
- •Family history of premature cardiovascular death
- •Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome
- •History of clinically significant arrhythmias or ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm)
- •Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa)
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- •This includes subjects with any of the following at screening:
- •Absence of regular supraventricular rhythm
- •Clinically significant PR (PQ) interval prolongation
- •Intermittent second or third degree AV block
- •Incomplete or complete bundle branch block.
- •Abnormal T-wave morphology
- •Prolonged QTcB >450 ms or shortened QTcB < 350 ms or family history of long QT syndrome Subject with borderline deviations from these criteria may be included if the deviations do not pose a safety risk, as judged by the investigator
- •Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator, especially:
- •Creatinine clearance (estimated using Cockcroft-Gault formula) < 60 mL/min
- •Alanine aminotransferase (ALT) > 1.5 x upper limit of normal or bilirubin > 3 x upper limit of normal
- •Positive drugs of abuse test result
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening
- •Donation or loss of greater than 100 mL of blood within the 3 months prior to screening or planned blood donation during the study until after final visit
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration
- •Failure to satisfy the investigator of fitness to participate for any other reason
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
APD421
Experimental
干预措施: APD421 (Drug)
APD421 + ondansetron
Experimental
干预措施: APD421 (Drug)
APD421 + ondansetron
Experimental
干预措施: Ondansetron (Drug)
结局指标
主要结局
ddQTcF
时间窗: 0-6 hours
Placebo-corrected change-from-baseline QTcF interval
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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