ISRCTN85791974已完成1 期
A Phase I, randomized, open-label, single-dose, three-period crossover bioequivalence and food effect study with orally administered mavodelpar tablet and capsule formulations in healthy subjects
Reneo Pharma Ltd (United Kingdom)0 个研究点目标入组 32 人开始时间: 2023年10月10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
- 32
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 male and female subjects, between 18 and 60 years of age, inclusive at Screening.
- •2. Female subjects: negative pregnancy test at Screening (Serum) and Day -1 of the first treatment period (Urine).
- •3. Must agree to adhere to the contraception requirements defined in the study protocol.
- •4. A body mass index (BMI) of 18-32 kg/m2 at Screening (BMI = body weight (kg) / [height (m)]2)
- •5. No clinically significant history of previous allergy/sensitivity to mavodelpar or any of the excipients contained within the IMP.
- •6. No clinically significant abnormal test results for serum biochemistry, haematology, coagulation and/or urine analyses within 35 days before the first dose administration of the IMP.
- •7. Negative urinary drugs of abuse (DOA) screen (including alcohol), determined within 35 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator’s discretion).
- •8. Negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- •9. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 35 days before first dose of IMP including a PR interval >220 ms, QT interval heart rate corrected using Fridericia’s formula (QTcF) > 450ms.
- •10. No clinically significant abnormalities in vital signs (blood pressure, pulse and oral temperature) determined within 35 days before first dose of IMP.
- •11. Must be available to complete the study (including the follow-up visit).
- •12. Must satisfy an Investigator about his/her fitness to participate in the study.
- •13. Must provide written informed consent to participate in the study.
排除标准
- •1. A clinically significant history of gastrointestinal disorder likely to influence IMP administration and absorption.
- •2. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP. The exceptions are paracetamol (which may be taken as an analgesic to a maximum of 2 g in 24 h) and ibuprofen (which may be taken as an analgesic to a maximum of 1.2 g in 24 h).
- •3. Evidence of significant renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- •4. Veins not suitable for venepuncture and cannulation.
- •5. Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay Fever is allowed unless active.
- •6. A clinically significant history of drug or alcohol use (defined as the consumption of more than 14 units [for male and female subjects] of alcohol a week) within the past two years.
- •7. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
- •8. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP. (The washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- •9. Donation or loss of 450 mL or more blood within the 3 months before the first dose of IMP or plans to donate blood in the 3 months following completion of the study.
- •10. Dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc) that would prevent the subject from consuming a standardised meal, the high-fat, high-caloric meal, and gelatine capsule.
- •11. Unwilling or unable to swallow gelatine capsules.
- •12. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to Screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).
- •13. Female subjects who are pregnant, breastfeeding or lactating.
- •14. Received, or intend to receive, a COVID-19 vaccine injection within 35 days prior to first dose of IMP.
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