ACTRN12616001557426已完成1 期
A Phase 1, Single-Center, Open-label Study to Evaluate the Safety and Pharmacokinetics of Two Tablet Formulations of 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
- 14
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Healthy adult male or non-pregnant, non-lactating females, 18 to 65 years of age (inclusive) at the time of screening
- •- Body mass index (BMI) greater than or equal to 18 (kg/m2) (inclusive), and less than or equal to 35 (kg/m2) (inclusive), and a minimum body weight of 45 kg
- •- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study
- •- A female subject of childbearing potential with a negative pregnancy test agrees to abstinence or use of condoms plus one other acceptable form of contraception; i.e. intrauterine device, hormonal contraception, or a female diaphragm, until 4 weeks after dosing with study drug – OR – has only same-sex partners, when this is her preferred and usual lifestyle
- •- Male subjects with female partners of childbearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug
- •- Negative urine drug/alcohol testing at screening and check-in (Day -1). Screening urine drug/alcohol testing may be repeated once if deemed appropriate by the site Investigator
- •- Willing to abstain from consuming grapefruit- or Seville orange-containing products from 14 days prior to first dose of study medication through follow-up
排除标准
- •- Use of any prescription or over-the-counter (OTC) medication, including herbal products and supplements, within the 14 days or 5 half-lives prior to Day 1 (whichever is longer). Use of less than or equal to 2g paracetamol per day is allowed prior to and during the study.
- •- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C antibodies (HCV)
- •- Use of more than two tobacco/nicotine-containing products per month within 6 months prior to the first study drug administration
- •- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- •- Regular alcohol consumption of greater than 14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •- History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticarial or multiple drug allergies
- •- Blood donation or significant blood loss within 30 days prior to screening
- •- Plasma donation within 14 days prior to the first study drug administration
- •- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half-lives, whichever is longer
- •- surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant
- •- Personal or family history of prolonged QT syndrome or family history of sudden death
- •- QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening,or prior to dosing, unless deemed clinically insignificant by the Investigator
- •- Screening ECG with QRS and/or T-wave judged to be unfavorable for a consistently accurate QT measurement as judged by the Investigator
- •- Evidence of atrial fibrillation, atrial flutter, complete bundle branch or heart block, Wolff-Parkinson-White Syndrome, or cardiac pacemaker at screening or prior to dosing
- •- Semi-supine resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg
- •- Resting HR less than 45 bpm or greater than 90 bpm at screening or prior to dosing.
- •- Hypersensitivity or history of idiosyncratic reaction to any components or excipients of the investigational formulation
- •- Active infection
- •- Participant is febrile, temperature greater than 37.5 degrees C assessed at screening or prior to dosing
- •- Any acute illness within 30 days prior to Day 1 unless deemed clinically insignificant by the Investigator and discussed with the Sponsor.
- •- History of seizure within the past 5 years, whether epileptic, paroxysmal, or of unknown origin
- •- Failure to satisfy the Investigator of fitness to participate for any other reason
- •- History or presence of any other medical condition that makes the participant unsuitable for the study in the opinion of the Investigator.
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