NCT02369172已完成1 期
A Single-centre, Open-label Study in Healthy Men to Investigate the Effect of Repeated Oral Doses of ASP2151 on the Pharmacokinetics of Bupropion
Maruho Europe Limited1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年2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
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Bupropion
研究概览
简要总结
CYP2B6 is involved in the metabolism of many drugs. So, it is important to assess in vivo the effect of ASP2151 on that enzyme to determine any possible drug interactions. The aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2B6 probe substrate bupropion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A body mass index (Quetelet index) in the range 18.0-30.
- •Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- •Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.
- •Willingness to give written consent to have data entered into The Overvolunteering Prevention System.
排除标准
- •Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
- •Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).
- •Platelet counts outside normal limits (129,000-346,000/μL).
- •Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- •Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
- •History of bleeding diathesis, head injury, intracranial mass lesions, hydrocephalus, epilepsy, seizures, depression, self-harm (or thoughts of self-harm) or eating disorders.
- •Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
- •Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as >3), or sensitivity to trial medication.
- •Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4, CYP2C8, CYP2B6, CYP2D6 or CYP2C19 metabolic pathway.
- •Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen).
- •Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.
- •Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly.
- •Current smoker or history of regular use of tobacco or nicotine-containing products within the previous 6 months.
- •Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40_100 beats/min. However, if the investigator deems the result to be not clinically significant the subject may be included.
- •Possibility that the volunteer will not cooperate with the requirements of the protocol.
- •Evidence of drug abuse on urine testing.
- •Positive test for hepatitis B, hepatitis C, HIV1 or HIV
- •Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
- •Objection by General Practitioner (GP) to volunteer entering trial.
研究组 & 干预措施
Bupropion + ASP2151
Other
400 mg ASP2151 followed by 150 mg Bupropion
干预措施: Bupropion (Drug)
Bupropion + ASP2151
Other
400 mg ASP2151 followed by 150 mg Bupropion
干预措施: ASP2151 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Bupropion
时间窗: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29
Peak Plasma Concentration (Cmax) of Bupropion
时间窗: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29
次要结局
- Number of Participants With Serious and Non-Serious Adverse Events(Up to 32 days after the last dose)
研究者
研究点 (1)
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