ISRCTN14891060已完成1 期
A two-part phase 1 study to evaluate the pharmacokinetic profile of ALXN2050 modified release prototype formulations and immediate release reference tablet in healthy adult participants
Alexion Pharmaceuticals (United States)0 个研究点目标入组 45 人开始时间: 2023年3月14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
- 45
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. Participant must be 18 to 55 years inclusive at the time of signing the informed consent.
- •2. Healthy males or non-pregnant, non-lactating healthy females.
- •3. Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the
- •Investigator or designee.
- •4. BMI within the range of 18.0 to 30.0 kg/m² (inclusive), with a minimum body weight of 50.0 kg at screening.
- •5. Female participants of childbearing potential and male participants must follow protocol specified contraception guidance.
- •6. Capable of giving signed informed consent as described in the clinical protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
排除标准
- •1. History of clinically significant respiratory, cardiovascular, dermatological, hepatic, renal, GI, endocrinological, haematological, psychological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
- •constituting a risk when taking the study intervention; or interfering with the interpretation of
- •2. History of meningococcal infection.
- •3. History of clinically significant hypersensitivity reactions to commonly used antibacterial agents, including beta lactams, penicillin, aminopenicillins, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to properly provide either empiric antibiotic therapy or treat an active infection.
- •4. History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •5. History of significant multiple and/or severe allergies (eg, drug, latex allergy, band aids, adhesive dressing, or medical tape). Hay fever is allowed unless it is active.
- •6. History of seizures including childhood seizures.
- •7. History of significant head injury, or head trauma requiring medical evaluation.
- •8. History of malignancy within 5 years of screening, with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- •9. Any previous procedure, including history of stomach or intestinal surgery or resection, cholecystectomy, gallstones, TIPS, or surgical shunt, that could alter absorption or excretion of orally administered drugs.
- •10. Significant current or chronic history of liver disease.
- •11. Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
- •12. Participants who do not have suitable veins for multiple venipunctures/cannulation as assessed by the Investigator or delegate at screening
- •13. Participants who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies (other than up to 4 g paracetamol per day, hormonal contraception and HRT) in the 14 days before first study intervention administration. COVID-19 vaccines are accepted concomitant medication. Exceptions may apply, as determined by the Investigator.
- •14. Participants who have taken any CYP or P-gp inhibitors or inducers within 14 days prior to first administration of study intervention.
- •15. Donation of whole blood or loss of greater than 400 mL of blood from 3 months prior to first dosing, or donation of plasma from 30 days before first dosing.
- •16. Receipt of blood products within 6 months prior to first dosing.
- •17. Participants who have received any study intervention (IMP) in a clinical research study within the 90 days, or less than 5 elimination half-lives, whichever is longer, prior to first planned dose.
- •18. Participants who have taken part in Part 1 are not permitted to take part in Part 2.
- •19. The following laboratory evaluations at screening, including:
- •19.1. Serum creatinine > upper limit of normal (ULN)
- •19.2. Alanine aminotransaminase (ALT) > ULN; Aspartate transaminase (AST) > ULN; Alkaline phosphatase (ALP) > ULN; or Total bilirubin > ULN
- •19.3. Hemoglobin (Hb) < LLN, white blood cell count < LLN
- •19.4. Abnormal coagulation profile including, platelet count < LLN, activated partial thromboplastin time > ULN, international normalized ratio > ULN reference range, or prothrombin time > ULN.
- •20. Evidence of
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