An Open-label, Randomized, 2-period Crossover Study to Compare the Pharmacokinetics of a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection Using an Auto-Injector Device and Manual Injection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 36
- 主要终点
- Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)
研究概览
简要总结
The purpose of the study is to compare Pharmacokinetics of liquid etanercept that is administered to healthy subjects aged 18-55 by an auto-injector device and manual injection (each subject received both injections).
详细描述
This single-center, randomized, open-label, 2-period, 2-sequence, 2-treatment, crossover study in healthy men and women compared the pharmacokinetics (PK) and safety profiles of two 50-mg subcutaneous (SC) injections of etanercept liquid (in a 1.0-mL prefilled syringe): (1) using a disposable auto-injector device, and (2) using a standard manual injection. Each subject received both injections in the abdomen, separated by a washout period of 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 是
入选标准
- •Healty men and women
- •Aged 18-55 years at time of screening
- •BMI 18-31 kg/m2 inclusive
- •Free of any clinically significant disease
- •Willing to reside in research facility 4 consecutive nights 2 times and to attend follow up visits
- •Willing to sign consent
- •Negative HIV, hepatitis B and C, and urine pregnancy tests
排除标准
- •Unstable medical condition (hospitalized within 30 days, myocardial infarction or major surgery within 6 months, or seizure within 12 months of study day 1)
- •Current active infecton, history of infections, or condition which may predispose infection (such as diabetes)
- •Clinically significant abnormality in laboratory samples done while screening
- •history of tuberculosis
- •donated blood within 30 days of screening
- •Use of prescription or over-the-counter medication during the study/
- •History of smoking or use of tobacco within 30 days of screening
- •Positive urine scree for alcohol or drugs of abuse at screening or the day prior to dosing
- •Unwilling to pracitce contraception for the duration ot the study
- •Any other condition which could interfere with obtaining data required by the protocol
研究组 & 干预措施
A-etanercept (ENBREL®) by auto-injector
Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL)
干预措施: Auto-injector device (Device)
A-etanercept (ENBREL®) by auto-injector
Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL)
干预措施: Etanercept (ENBREL®) (Drug)
B-etanercept (ENBREL®) by Manual injection
Single dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment)
干预措施: Etanercept (ENBREL®) via Manual injection (Other)
结局指标
主要结局
Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)
时间窗: 28 days
28 days after receiving treatment in Period 1, subjects return to the facility on an outpatient basis to receive the alternate treatment in Period 2. Procedures performed in the first period are repeated in the second period.
次要结局
- Measure of vital signs changes from baseline to end of each treatment period(Baseline and 28 days following each treatment)
- PK parameters of the area under the serum drug concentration (t z)(28 days: timepoint at which outcome measure is assessed following each treatment arm)
- Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment(Predose in each treatment period and 28 days following dosing in treatment period B)
- Safety Events measured by adverse events and how they relate to study drug(28 days-timepoint at which outcome measure is assessed following each treatment arm)
- Profile PK parameters of AUC (0-∞)(28 days: timepoint at which outcome measure is assessed following each treatment arm)
- Any Clinically Significant changes in clinical laboratory tests will be noted(Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2)
- Profile PK parameters of AUC (C max )(28 days: timepoint at which outcome measure is assessed following each treatment arm)
- PK parameters of the area under the serum drug concentration (t 1/2)(28 days: timepoint at which outcome measure is assessed following each treatment arm)