ISRCTN17748514已完成1 期
A Phase I, interwoven, first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of A3907, a first-in-class IBAT inhibitor
Albireo (Sweden)0 个研究点目标入组 75 人开始时间: 2022年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
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
- •Healthy male subjects and female subjects of nonchildbearing potential aged between 18 and 60 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m² (inclusive)
排除标准
- •1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee)
- •2. History of any illness that, in the opinion of the investigator (or designee), might confound the results of the study or pose an additional risk to the subject by their participation in the study
- •3. Significant history of gastric retention, constipation, urinary retention, urinary obstruction or difficulty in voiding, as determined by the investigator (or designee)
- •4. History of narrow-angle glaucoma
- •5. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including the active ingredient, excipients, or related compounds
- •6. History of stomach or intestinal surgery or resection or other medical condition that would potentially alter the absorption, metabolism, and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed)
- •7. Planned weight loss, being on any weight-reducing diet, or being on or planning to start any prescription or over-the-counter anti-obesity agent
- •8. Confirmed (e.g., two consecutive measurements separated by 10 minutes) systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, pulse rate >90 or <40 bpm, or oral body temperature >37.8°C or <35.5°C
- •9. Clinical evidence of liver disease or injury as indicated by the following and confirmed by repeat testing:
- •9.1. Alanine transaminase or AST >1.5× ULN (upper limit of normal)
- •9.2. Total bilirubin >1.5× ULN (total bilirubin >1.5× ULN is acceptable if direct bilirubin <35%)
- •9.3. Alkaline phosphatase >2× ULN
- •10. History or presence of clinically significant impaired renal function as indicated by abnormal creatinine, urea, or urinary constituents as determined by the investigator (or designee) or glomerular filtration rate of <80 ml/min/1.73 m² at screening based on the Chronic Kidney Disease Epidemiology Collaboration creatinine equation
- •11. White blood cells <3.5 × 109/L or platelets <100 × 10e9/l
- •12. History of alcoholism or drug/chemical abuse within 2 years prior to check-in
- •13. Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 ml) of beer or lager, 1 glass (125 ml) of wine, or 1/6 gill (25 ml) of spirits
- •14. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in
- •15. Positive hepatitis B surface antigen or hepatitis C antibody test result within 3 months prior to dosing, or positive hepatitis panel or positive human immunodeficiency virus test at screening. Subjects with positive hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory hepatitis C RNA test is negative.
- •16. Participation in a clinical study involving administration of an investigational drug (new chemical entity) within 90 days prior to dosing or in >4 clinical studies within 12 months prior to dosing
- •17. Use or intent to use any me
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