NCT01268124已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HTC-867 Administered Orally to Healthy Japanese Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 56 人开始时间: 2008年12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
- 56
- 主要终点
- Safety will be measured by vitals signs, labs and electrocardiograms (ECG's).
研究概览
简要总结
This is a phase 1, randomized (a process that is used to decide whether you will take study drug or a placebo during the study), inpatient study which will assess the safety and tolerability of HTC-867 in healthy male Japanese subjects.
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, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •Medical History
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any unstable medical condition.
- •History of seizures.
- •History of cardiac disorders (other than hypertension) including but not limited to valvular disease, congestive heart failure, angina pectoris, myocardial infarction, or arrhythmia.
- •Any significant cardiovascular disease, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (eg, resection of liver, kidney, gallbladder, or gastrointestinal tract).
- •Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1).
- •History of drug abuse within 1 year before study day
- •Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
- •Physical and Laboratory Findings
- •Clinically significant electrocardiogram (ECG) abnormalities.
- •Any clinically important deviation from normal limits in physical examination findings, vital sign measurements, 12-lead ECGs, or clinical laboratory test results.
- •Positive serologic findings for human immunodeficiency virus (HIV) antigen and antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies.
- •Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine [PCP]).
- •Troponin T or CK-MB levels above reference range at screening. Allergies and Adverse Drug Reactions
- •History of any clinically important drug allergy (eg, relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to ingredient in the test articles, angioedema).
- •Prohibited Treatments
- •Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day
- •Tobacco use or the consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 72 hours before study day 1 until the end of the inpatient confinement period.
- •Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 until the end of the inpatient confinement period.
- •Use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1 (St. John wort is prohibited within 30 days of study day 1).
- •Donation of blood within 90 days before study day
- •Subjects deemed by the investigator to be inappropriate according to the inclusion criteria in the study and according to the screening examination.
研究组 & 干预措施
Treatment
Experimental
干预措施: HTC-867 (Drug)
结局指标
主要结局
Safety will be measured by vitals signs, labs and electrocardiograms (ECG's).
时间窗: 7 months
次要结局
- Pharmacokinetics.(7 months)
研究者
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