ISRCTN11628974已完成1 期
A multiple dose study to evaluate the pharmacokinetics of an acoramidis (AG10) modified release tablet formulation in healthy subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
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. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in one cohort
- •3. Aged 18 to 65 years inclusive at the time of signing informed consent
- •4. Must agree to adhere to the contraception requirements
- •5. Healthy males or non-pregnant, non-lactating healthy females
- •6. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
- •7. Body weight >50 kg at screening
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- •4. Subjects with a history of cholecystectomy or gall stones
- •5. Subjects who do not have suitable veins for multiple venepunctures/cannulations as assessed by the investigator or delegate at screening
- •6. Evidence of current SARS-CoV-2 infection within 2 weeks of first IMP administration
- •7. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in the clinical study protocol). Subjects with Gilbert’s Syndrome are allowed
- •8. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and a negative highly sensitive urine pregnancy test at each admission)
- •10. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer. Subjects enrolled in Cohort 1 will not be permitted to enrol in Cohort 2. Subjects who have received acoramidis in the previous Quotient Sciences study QSC204480 (AG10-009) are permitted to take part
- •11. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •12. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day or HRT/hormonal contraception) in the 14 days before IMP administration. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator
- •13. History of any drug or alcohol abuse in the past 2 years
- •14. 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)
- •15. A confirmed positive alcohol breath test at screening or admission
- •16. 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
- •17. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •18. Confirmed positive drugs of abuse test result (drugs of abuse tests are listed in the clinical study protocol)
- •19. Male subjects with pregnant or lactating partners
- •20. Subjects who are, or are immediate family members of, a study site or Sponsor employee
- •21. Failure to satisfy the investigator of fitness to participate for any other reason
- •22. In the judgment of the investigator or Sponsor, has any clinically important ongoing medical condition or laboratory abnormality or other condition that might jeopardise the subject’s safety, increase their risk from participation, or interfere with the study
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