JPRN-jRCT2080222845未知1 期
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Dose of TAK-792 in the Healthy Adult Subjects
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 103 人开始时间: 2015年5月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •1.In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- •2.The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •3.The participant is a healthy male of Japanese descent (born to Japanese parents and grandparents) or Caucasian descent (born to Caucasian parents and grandparents).
- •4.The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
- •5.The participant weighs at least 50 kg and has a body mass index (BMI) between 18.5 and 25.0 kg/m^2 for Japanese, BMI between 18.5 and 30.0 kg/m^2 for Caucasian, inclusive at Screening and Check-in (Day -1).
- •6.A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
排除标准
- •1.The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of study medication.
- •2.The participant is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- •3.The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- •4.The participant has a positive urine drug result for drugs of abuse at Screening.
- •5.The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- •6.Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
- •7.The participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
- •8.Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash.
- •9.Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [eg, cholecystectomy]).
- •10.Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
- •11.Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening.
- •12.Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening.
- •13.The participant has poor peripheral venous access.
- •14.The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration.
- •15.The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study drug administration.
- •16.The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration.
- •17.Participant has a Screening abnormal (clinically significant) ECG.
- •18.Participant has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 the upper limits of normal.
- •19.Participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
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