NCT01264224已完成1 期
A Dose-block Randomized, Double-blind, Placebo-controlled Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of PAC-14028 After Oral Administration in Healthy Male Volunteers.
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
- 60
- 试验地点
- 1
- 主要终点
- Safety/Tolerability
研究概览
简要总结
- Primary Objective:
- To evaluate safety and tolerability of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
- Secondary Objective:
- To evaluate pharmacokinetics and pharmacodynamics of single and multiple oral dosing of PAC-14028 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged 20 to 45 years at the time of screening
- •Whose weight is 50kg or more, but less than 90 kg, and whose body mass index(BMI) is 19.0 kg/m^2 or more but less than 27 kg/m^2
- •BMI (kg/m^2) = weight(kg) /{height(m)}^2
- •Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.
排除标准
- •Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system, psychical disorders or blood tumor
- •Who has gastrointestinal diseases or operation history which may interfere study drug absorption (however, except simple appendectomy and hernioplasty )
- •Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
- •Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
- •Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
- •Smoker or who has stopped smoking within previous 1 month or shows positive result at cotinine test.
- •Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
- •Who consistently consumes alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol)
- •Who has participated in other clinical study within 12 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)
- •Who has had bleeding or blood collection and donation over 400 mL within 12 weeks before study drug administration
- •Whose vital sign measured at sitting position after resting at least 5 minutes is as following
- •Low blood pressure (Systolic pressure: 90 mmHg or less, Diastolic pressure: 50 mmHg or less)
- •High blood pressure (Systolic pressure: 140 mmHg or higher, Diastolic pressure: 90 mmHg or less)
- •Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
研究组 & 干预措施
PAC-14028
Experimental
干预措施: PAC-14028 (Drug)
结局指标
主要结局
Safety/Tolerability
AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests
次要结局
- Pharmacokinetics/dynamics
研究者
研究点 (1)
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