An Open-Label, Randomized, Two-period Crossover Study To Compare Relative Bioavailability of Two Formulations of Moroctocog Alfa (Af-cc) In Subjects With Moderately Severe Or Severe Hemophilia A (FVIII:C </=2%)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)
研究概览
简要总结
This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.
详细描述
This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
- •Negative test for facto VIII inhibitor.
- •If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
- •Ability to abstain from use of FVIII products for 72 hours at a time.
排除标准
- •History of any positive test result for factor VIII inhibitor.
- •Presence of any bleeding disorder in addition to Hemophilia A.
- •Body weight less than 50 kg.
- •History of alcoholism.
- •Treatment with investigational drug or device within 30 days prior to the Screening visit.
研究组 & 干预措施
Sequence 1
Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.
干预措施: moroctocog alfa (AF-CC) (Drug)
Sequence 2
Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.
干预措施: moroctocog alfa (AF-CC) (Drug)
结局指标
主要结局
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)
时间窗: Periods 1 and 2, Day 1 through 4
次要结局
- Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery)(Periods 1 and 2, Day 1 through Day 4)