ACTRN12618000650291已完成1 期
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PRAX-114 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
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
- •A participant must meet the following criteria at Screening (Days -28 to -2) to be eligible to participate in this study:
- •1. The subject must be a female of nonchildbearing potential or male and between the ages of 18 and 55 years, inclusive. Documentation of hysterectomy, bilateral tubal ligation, or postmenopausal status must be available for female subjects.
- •2. Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
- •3. 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
- •4. 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
- •5. The subject must be willing to sign an informed consent document indicating that he/she understands the purpose of the study and the procedures that are required for the study and that he/she is willing to participate in the study.
排除标准
- •A participant who meets any of the following criteria at Screening (unless otherwise specified) will be excluded from this study:
- •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 less than 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. Smokers and/or 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 supplements 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 great than or equal to 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. Abuse is defined as consumption of greater than 2 standard drinks per day (14 standard drinks per week)
- •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
相似试验
已完成
1 期
Phase I Multiple Ascending Dose study of TRC150094 on overweight/obese male and female subjects.CTRI/2009/091/000601Torrent Pharmaceuticals Limited28
已完成
1 期
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GRX-917 in Healthy SubjectsMental Health - DepressionAnxietyACTRN12621000160831Gaba Therapeutics Australia Pty Ltd a subsidiary of Gaba Therapeutics, Inc102
已完成
1 期
A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy VolunteersPulmonary Nontuberculous Mycobacteria InfectionsInfection - Other infectious diseasesACTRN12621001702808MannKind Corporation40
已完成
1 期
A Phase 1, Double-Blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Flecainide Acetate Inhalation Solution to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy VolunteersRecent Onset Paroxsymal Atrial FibrillationCardiovascular - Other cardiovascular diseasesACTRN12616001156471InCarda Therapeutics Australia44
已完成
1 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FlecIH-101 Versus Placebo in Healthy VolunteersCardiovascular - Other cardiovascular diseasesParoxysmal atrial fibrillationACTRN12618001239257InCarda Therapeutics Australia, Pty, Ltd22