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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-01-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Healthy Men and Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Auto-injector device

Intervention Type DEVICE

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®)

Intervention Type 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)

B-etanercept (ENBREL®) by Manual injection

Single dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment)

Group Type OTHER

Etanercept (ENBREL®) via Manual injection

Intervention Type OTHER

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

Interventions

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Auto-injector device

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)

Intervention Type DEVICE

Etanercept (ENBREL®) via Manual injection

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

Intervention Type OTHER

Etanercept (ENBREL®)

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)

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

Accepts Healthy Volunteers

Yes