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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to Reach Cmax (Tmax) of ALXN2050
研究概览
简要总结
The primary objectives of this study are to investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant, non-lactating healthy females.
- •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.
- •BMI within the range of 18.0 to 30.0 kg/m2 (inclusive), with a minimum body weight of 50.0 kg at screening.
- •Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
排除标准
- •History of clinically significant respiratory, cardiovascular, dermatological, hepatic, renal, GI, endocrinological, hematological, 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 data.
- •History of meningococcal infection.
- •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.
- •History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •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.
- •History of seizures including childhood seizures.
- •History of significant head injury, or head trauma requiring medical evaluation.
- •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.
- •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.
- •Significant current or chronic history of liver disease.
- •Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome).
研究组 & 干预措施
Cohort 1
Regimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.
Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions.
Optional Regimens C, D, E, and F
干预措施: ALXN2050 MR Prototype Tablet (Drug)
Cohort 1
Regimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.
Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions.
Optional Regimens C, D, E, and F
干预措施: ALXN2050 Immediate Release (IR) Tablet (Drug)
Cohort 2
Regimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.
Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions.
Optional Regimens: I, J, K, and L
干预措施: ALXN2050 Immediate Release (IR) Tablet (Drug)
Cohort 2
Regimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions.
Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions.
Optional Regimens: I, J, K, and L
干预措施: ALXN2050 MR Prototype Mini-Tablet (Drug)
结局指标
主要结局
Time to Reach Cmax (Tmax) of ALXN2050
时间窗: Up to 96 hours postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050
时间窗: Up to 96 hours postdose
Maximum Observed Plasma Concentration (Cmax) of ALXN2050
时间窗: Up to 96 hours postdose
次要结局
- Number of Participants With Adverse Events (AEs)(Day 1 up to Day 15)