NL-OMON50050已完成不适用
A Double Blinded, Placebo Controlled, Crossover Infusion Study of Respiratory Pharmacodynamics of ENA-001 in Conjunction with Propofol, Hypoxia, and Hypercapnia - Crossover Study of the PD of ENA-001 and hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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
- 18 至 64（—）
入选标准
- •The subject must meet ALL the criteria listed below for entry at baseline:
- •1. Subjects must be willing to give written informed consent for the trial and
- •able to adhere to dose and visit schedules.
- •2. Male and female, >18 to *55 years of age.
- •3. Subject must weigh *50 to *100 kg.
- •4. Subjects must have Body Mass Index [weight/height2 (kg/m2)] between 18 to 30
- •kg/m2 (inclusive).
- •5. Have no clinical or electrocardiographic signs of ischemic heart disease as
- •determined by the Investigator with normal cardiac intervals appropriate for
- •their gender. The Screening 12 lead ECG conduction intervals must be within
- •gender specific normal range (e.g., QTcf female * 470 msec QTcF males * 450
- •msec, PR interval * 220 msec). ECGs are to be judged by the investigator or
- •sub-investigator as per standardized procedures.
- •6. Subjects* clinical laboratory tests (blood hematology, blood chemistry,
- •coagulation and urinalysis) must not include any clinically significant
- •abnormalities.
- •7. Vital sign measurements must be within the following ranges during screening
- •and on Day -1: (Individuals with values outside (or indicate lower or higher)
- •of these ranges may be enrolled if clinically acceptable to the investigator
- •and sponsor.
- •a. body temperature, >35.5*C to *37.5*C
- •b. systolic blood pressure, >90 to *150 mm Hg
- •c. diastolic blood pressure, >40 to *95 mm Hg
- •d. pulse rate, >40 to *100 bpm
- •8. Non-vasectomized men must agree to use a condom with spermicide (when
- •marketed in the country), double-barrier contraception, abstain from
- •heterosexual intercourse, or have a sole-sexual partner of non-childbearing
- •potential during the trial and for 3 months after stopping the medication. Male
- •subjects must agree not to donate sperm from the time of dosing until 90 days
- •after dosing.
- •9. Women of childbearing potential (defined as all women who are not surgically
- •sterile or postmenopausal for at least 1 year prior to informed consent) must
- •have a negative pregnancy test prior to enrolment and must agree to the
- •following contraception requirement from screening through at least 3 months
- •after the last dose of study drug:
- •a. Be sexually inactive (abstinent)
- •b. Intrauterine device in place for at least three months prior to dosing with
- •a barrier method (condom or diaphragm) and spermicide throughout the study.
- •c. Double barrier methods (e.g., condom and diaphragm) with spermicide for at
- •least 14 days prior to dosing and throughout the study.
- •d. Surgical sterilization of the partner (vasectomy at least six months prior
- •to dosing) with a barrier method (e.g., condom or diaphragm) and spermicide
- •throughout the study.
- •e. Female subjects who claim to be sexually inactive but become sexually active
- •during the course of the study must agree to use a double barrier method (e.g.,
- •condom and diaphragm) with spermicide from the time of the start of sexual
- •activity through completion of the study.
- •In addition, female subjects of childbearing potential must be advised to
- •remain sexually inactive or to keep the same birth control method for at least
- •14 days following study medication administration.
- 另有 3 项未显示
排除标准
- •The subject will be excluded from entry if ANY of the criteria listed below are
- •met at baseline:
- •1. Current diagnosis of psychiatric disease requiring daily medication,
- •including controlled or uncontrolled schizophrenia, current or recently treated
- •depressive disorders, or Columbia-Suicide Severity Rating Scale (C-SSRS)
- •indicative of suicidal ideation or behavior at screening and day -1.
- •2. Past history of the anxiety disorder including panic attack, depression,
- •obsessive compulsive disorder, phobias restricting normal daily function,
- •social anxiety, and paranoia.
- •3. History of alcohol abuse (more than an average of 2-drinks per day) within
- •the past 2 years.
- •4. History of drug abuse within the past 2 years.
- •5. History of regular smoking within the past year (>5 per week means
- •exclusion).
- •6. Failure to take or test positive of the drug of abuse tests at screening or
- •7. Positive for HIV, or Hepatitis B or C at screening.
- •8. Blood donation or blood loss within 60 days of screening or plasma donation
- •within 7 days of screening.
- •9. Subjects with a history of bleeding disorders or coagulopathies.
- •10. History of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary
- •disease, sleep apnea or any other ventilatory / lung disease.
- •11. Treatment with another investigational drug within 3 months prior to
- •screening or having participated in more than four investigational drug studies
- •within 1 year prior to screening.
- •12. History of moderate to severe motion sickness.
- •13. Subjects who are unwilling to remove excessive facial hair preventing
- •sealing of the occlusive face mask.
- •14. Subjects who, in the opinion of the investigator, will not be able to
- •participate optimally in the study.
- •15. Any surgical or medical condition which might significantly alter the
- •distribution, metabolism or excretion of any drug. The investigator should be
- •guided by evidence of any of the following, and be discussed with the sponsor
- •prior to enrollment into the trial:
- •a. history of pancreatic injury or pancreatitis;
- •b. history or presence of liver disease or liver injury;
- •c. history or presence of impaired renal function as indicated by clinically
- •significant elevation in creatinine, BUN/urea, urinary albumin, or clinically
- •significant urinary cellular constituents ; or
- •d. history of urinary obstruction or difficulty in voiding.
- •16. Subject who has a history of any infectious disease within 4 weeks prior to
- •drug administration that in the opinion of the investigator, affects the
- •subject*s ability to participate in the trial.
- •17. Subjects who are part of the study staff personnel or family members of the
- •study staff personnel.
- •18. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic
- •reactions or asthmatic episodes) which, in the opinion of the investigator and
- •sponsor, interfere with their ability to participate in the trial.
- •19. Subjects who have a history of malignancy and are in remission >2 years.
- •20. Personal or family history of malignant hyperthermia.
- •21. Personal or family history of arrhythmias or ECG conductance abnormalities.
- 另有 3 项未显示
研究者
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