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

June 9, 2016 updated by: Amgen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

36

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Device: 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)
Drug: 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)
Other: B-etanercept (ENBREL®) by Manual injection
Single dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)
Time Frame: 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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile PK parameters of AUC (0-∞)
Time Frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
PK parameters of the area under the serum drug concentration-time curve from time zero to infinity
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
Time Frame: 28 days-timepoint at which outcome measure is assessed following each treatment arm
Incidence, severity, and relationship to study drug of adverse events for each subject
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
Time Frame: Baseline and 28 days following each treatment
Changes from baseline in vital signs (includes blood pressure-systolic and diastolic; and heart rate per minute) and physical examinations
Baseline and 28 days following each treatment
Any Clinically Significant changes in clinical laboratory tests will be noted
Time Frame: Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2
Laboratory variables summarized separately from adverse events and compared to normal ranges; samples will be analyzed by standard procedures
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
Time Frame: Predose in each treatment period and 28 days following dosing in treatment period B
Blood samples collected to measure seroreactivity to etanercept
Predose in each treatment period and 28 days following dosing in treatment period B
Profile PK parameters of AUC (C max )
Time Frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
maximum observed concentration
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)
Time Frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
terminal phase half-life
28 days: timepoint at which outcome measure is assessed following each treatment arm
PK parameters of the area under the serum drug concentration (t z)
Time Frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
terminal phase half-life
28 days: timepoint at which outcome measure is assessed following each treatment arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20030121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Men and Women

Clinical Trials on Auto-injector device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe