Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection

Amgen36 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Men and Women

Interventions

Auto-injector deviceDEVICE

Single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)

Etanercept (ENBREL®) via Manual injectionOTHER

Single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via manual injection (reference treatment) to compare to the auto-injection

Etanercept (ENBREL®)DRUG

Single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)

Eligibility

Healthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)

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.

Time frame: 28 days

Secondary Outcomes

Profile PK parameters of AUC (0-∞)

PK parameters of the area under the serum drug concentration-time curve from time zero to infinity

Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm

Safety Events measured by adverse events and how they relate to study drug

Incidence, severity, and relationship to study drug of adverse events for each subject

Time frame: 28 days-timepoint at which outcome measure is assessed following each treatment arm

Measure of vital signs changes from baseline to end of each treatment period

Changes from baseline in vital signs (includes blood pressure-systolic and diastolic; and heart rate per minute) and physical examinations

Time frame: Baseline and 28 days following each treatment

Any Clinically Significant changes in clinical laboratory tests will be noted

Laboratory variables summarized separately from adverse events and compared to normal ranges; samples will be analyzed by standard procedures

Time frame: Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2

Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment

Data from ClinicalTrials.gov

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