ACTRN12614000359639已完成1 期
A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of Orally Administered PRN1008 in healthy adult volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
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
- •1. Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening
- •2. Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 30.5 (kg/m2) (inclusive) and a minimum body weight of 45 kg
- •3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
- •4. If male, agrees to be sexually abstinent or to use a condom or other adequate barrier method of contraception when engaging in sexual activity from study check-in until 30 days post dosing completion of the follow-up visit. Participants will be advised to use adequate contraception for 30 days following the last administration of the study drug, and not to donate sperm during this same period of time.
- •5. Female participants must be surgically sterile or post-menopausal (no spontaneous menstrual period for at least one year, confirmed by FSH > 40 mIU/mL.
- •Sterilization procedure must have been completed at least 6 months prior to the first study drug administration. The following are acceptable:
- •a. Essure (Registered Trademark) sterilization (with a copy of the confirmation test) and be using an adequate barrier method (condom or diaphragm) throughout the study
- •b. bilateral tubal ligation and be using an adequate barrier method (condom or diaphragm) throughout the study
- •c. hysterectomy
- •d. bilateral oophorectomy
- •6. Negative urine drug/alcohol breath testing at screening and check-in (Day -1).
排除标准
- •1.Pregnant or lactating women, and male partners of women who are pregnant or lactating
- •2. Women of child-bearing potential
- •3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
- •4. Any active acute or chronic disease judged to be clinically significant by the Investigator
- •5. Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to the first study drug administration
- •6. Participant is febrile, temperature greater than 37.5 degrees Celsius.
- •7. History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration
- •8. History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies
- •9. Use of any vitamins or nutritional supplements within the 7 days prior to Day 1. Use of any prescription medication within the 14 days prior to the first study drug administration or five half-lives, whichever is longer
- •10. Blood donation or significant blood loss within 60 days prior to screening
- •11. Plasma donation within 14 days prior to the first study drug administration
- •12. Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 60 days prior to the first study drug administration or five half-lives, whichever is longer
- •13. Surgery within the past three months prior to the first study drug administration determined by the Investigator to be clinically relevant
- •14. Personal or family history of prolonged QT syndrome or family history of sudden death
- •15. QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, or deemed clinically insignificant by the PI
- •16. Screening ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement as judged by the Investigator
- •17. Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff-Parkinson-White Syndrome, or cardiac pacemaker at screening or baseline visit
- •18. Seated resting systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, or diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
- •19. Resting Heart rate less than 45 bpm or greater than 90 bpm at screening or baseline visit
- •20. Hypersensitivity or history of idiosyncratic reaction to any components or excipients of the investigational or placebo formulation
- •21. Regular alcohol consumption greater than 14 units per week (1 unit = one half pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •22. Failure to satisfy the Investigator of fitness to participate for any other reason
- •23. Active infection
- •24. History of seizure, whether epileptic, paroxysmal, or of unknown origin
- •25. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
- •26. Any acute illness within 30 days prior to Day 1
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