ISRCTN24120533已完成1 期
A study in healthy subjects designed to evaluate the pharmacokinetic profile of firibastat (QGC001) and metabolites EC33 and QGC515 following multiple dose administration of QGC001 immediate release and modified release formulations
Quantum Genomics (France)0 个研究点目标入组 30 人开始时间: 2022年2月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Healthy males or healthy females of non-childbearing potential
- •2. Age 18 to 55 years at the time of signing informed consent
- •3. Body mass index of 18.0 to 32.0 kg/m² as measured at screening
- •4. Must be willing and able to communicate and participate in the whole study
- •5. Must provide written informed consent
- •6. Must agree to adhere to the contraception requirements
排除标准
- •1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- •2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •3. Subjects who have previously been enrolled in this study (subjects who participated in study QSC118052 are allowed)
- •4. History of any drug or alcohol abuse in the past 2 years
- •5. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- •6. A confirmed positive alcohol breath test at screening or admission
- •7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative urine pregnancy test). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle stimulating hormone [FSH] concentration =40 IU/L)
- •10. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •11. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator
- •12. Subjects with BP <90/40 mmHg at screening and pre-dose
- •13. Subjects with Gilbert’s Syndrome
- •14. Confirmed positive drugs of abuse test result
- •15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •16. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- •17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •18. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •19. Donation or loss of greater than 400 mL of blood within the previous 3 months
- •20. Subjects who are taking, or have taken, any prescribed or over-the-counter drugs or herbal remedies (other than 4 g of paracetamol per day and HRT) in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the PI
- •21. Failure to satisfy the investigator of fitness to participate for any other reason
研究者
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