Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection
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
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2003
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedJune 15, 2016
June 1, 2016
3 months
June 4, 2015
June 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
28 days
Secondary Outcomes (8)
Profile PK parameters of AUC (0-∞)
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
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
Baseline and 28 days following each treatment
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
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
- +3 more secondary outcomes
Study Arms (2)
A-etanercept (ENBREL®) by auto-injector
ACTIVE COMPARATORSingle dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL)
B-etanercept (ENBREL®) by Manual injection
OTHERSingle dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment)
Interventions
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)
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
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 15, 2016
Study Start
October 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
June 15, 2016
Record last verified: 2016-06