ACTRN12622000460707尚未招募1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Assessthe Tolerability, Safety, and Pharmacokinetics of Single Ascending Oral Tablet Doses ofOPC-224333 in Healthy Male and Female Subjects (Arm 1)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Participants are required to meet the following inclusion criteria when assessed:
- •1) Male and nonchildbearing potential (NCBP) female participants between 18 and 55 years of age, inclusive.
- •2) Body mass index (BMI) between 19.0 to 32.0 kg/m2 (inclusive).
- •3) In good health as determined by:
- •a) Medical history
- •b) Physical examination
- •c) Neurological examination
- •d) Electrocardiogram (ECG)
- •e) Serum/urine biochemistry, hematology, and serology tests.
- •4) Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
- •5) Female participants who are surgically sterile (ie, have undergone bilateral oophorectomy or hysterectomy) or who have been postmenopausal for at least 12 consecutive months. This will be confirmed with follicle-stimulating hormone (FSH) assessment.
- •6) Male participants must agree to remain abstinent or to practice double-barrier forms
- •of birth control and refrain from sperm donation from trial screening through 90 days from the last dose of the IMP.
- •7) Participants who are nonsmokers (with an acceptable cotinine test), nontobacco
- •users, and nonvapers.
排除标准
- •Participants will be excluded if they meet any of the following exclusion criteria when
- •1) Clinically significant abnormality in past medical history or at the screening physical examination (including but not limited to clinical laboratory tests), that in the investigator’s or sponsor’s opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of the IMP. This includes, but is not limited to, history of or concurrent cardiac, hepatic (liver function tests > 1.5 × upper limit of normal [ULN] at screening/baseline), renal (estimated glomerular filtration rate per chronic kidney disease epidemiology formula <60 mL/min), neurologic, endocrine,
- •gastrointestinal, respiratory, hematologic, and immunologic disease.
- •2) History of drug and/or alcohol abuse within 2 years prior to screening.
- •3) History of or current hepatitis or acquired immunodeficiency syndrome or carriers
- •of hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV), and/or human immunodeficiency virus (HIV) antibodies. Exceptions are permitted for subjects with a prior history of infection with hepatitis A who have fully recovered and are experiencing no liver sequelae, or with hepatitis C who have been adequately treated to be considered cured with no liver sequelae.
- •4) History of any medically significant allergy.
- •5) A positive urine or breath alcohol test and/or a positive urine drug screen for substance of abuse at screening or upon check-in to the trial site.
- •6) Subject having taken an investigational drug within 30 days preceding screening or a biological investigational drug within 30 days or 5 half-lives (whichever is longer) preceding screening,
- •7) Any history of significant bleeding or hemorrhagic tendencies.
- •8) Any history of difficulty in donating blood.
- •9) Donation of blood or plasma within 30 days prior to dosing.
- •10) Subjects without a permanent physical residence.
- •11) Consumption of alcohol and/or food and beverages containing methylxanthines (caffeinated coffee, caffeinated tea, caffeinated soda, and chocolate), pomelo, grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 3 days prior to dosing.
- •12) Use of prescription drugs, over-the-counter drugs, herbal medication, or vitamin
- •supplements within 14 days or 5 half-lives, whichever is longer, prior to dosing and antibiotics within 30 days prior to dosing. The sponsor may allow exceptions only if the medication’s administration is deemed unlikely to impact the pharmacokinetic (PK) results.
- •13) Exposure to any substances known to stimulate hepatic microsomal enzymes
- •within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents).
- •14) Use of tobacco products or daily exposure to second-hand smoke within 2 months
- •prior to screening, which result in urine cotinine concentrations > 500 ng/mL, or serum cotinine concentrations > 20 ng/mL at screening or at check-in to the trial site.
- •15) Uncontrolled hypertension, defined as supine systolic blood pressure = greater than or equal to 140 mmHg and/or supine diastolic blood pressure = greater than or equal to 90 mmHg at screening or check-in, or symptomatic hypotension or orthostatic hypotension, which is defined as a decrease of = greater than or equal to 20 mmHg in systolic blood pressure and/or a decrease of = greater than or equal to 10 mmHg in diastolic blood pressure after at least 3 minutes
研究者
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