ACTRN12617001512314已完成1 期
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First in Human Study of PRAX-330 to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
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 50 Years（—）
- 性别
- Male
入选标准
- •1. Male subjects between ages 18-50 years (inclusive) at time of Screening
- •2. Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- •3. Resting supine vital signs at Screening within the following ranges:
- •-Systolic blood pressure (SBP) 90 to 140 mmHg
- •-Diastolic blood pressure (DBP) 40 to 90 mmHg
- •-Heart rate (HR) 40 to 100 beats per minute
- •4. Male subjects with female partners of childbearing potential must be using 2 acceptable methods of contraception, including at least one barrier method, from the day of first dose of study drug to at least 90 days after the last dose of study drug. Periodic abstinence and withdrawal are not acceptable methods of contraception
- •5. Willing and able to comply with the requirements of the protocol and directions from the clinic staff
- •6. Willing to avoid consumption of grapefruit, grapefruit juice and Seville oranges within 2 weeks prior to first dose of study drug until discharge from the clinic
- •7. Willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages within 2 weeks prior to first dose of study drug until discharge from the clinic
- •8. Understand and willing to sign informed consent
排除标准
- •1. Ongoing or history of any medical or surgical condition that, in the judgment of the Investigator, might jeopardize the subject’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug
- •2. Any abnormal electrocardiographic (ECG) findings at Screening judged to be clinically significant by the Investigator
- •3. Any abnormal laboratory value or physical examination findings at Screening that is judged by the Investigator as clinically significant
- •4. Hemoglobin <12 g/dL
- •5. Serology test positive for HIV, or hepatitis B or C at Screening.
- •6. Positive drug test for ethanol, barbiturates, cocaine, methamphetamines, Methadone, benzodiazepines, phencyclidine, tetrahydrocannabinols, methylenedioxymethamphetamine, opiates, or amphetamines at Screening and clinic Check-in
- •7. Positive urine cotinine test at Screening and Check-in
- •8. Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks or 5 times the terminal half-lives of the medication prior to first dose of study drug, whichever is longer and for the duration of the study.
- •9. Use of any experimental or investigational drug or device within 30 days prior to first dose of study drug or 5 half-lives of the drug, whichever is longer
- •10. Donation or loss of =400 mL blood within 8 weeks and/or donation of plasma within 7 days prior to initial dosing of study drug
- •11. History of drug or alcohol abuse within 12 months prior to initial dosing of study drug
- •12. Psychosocial or addictive disorders that would interfere with subject’s ability to give informed consent or could compromise compliance with the protocol
研究者
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