Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects

October 26, 2015 updated by: Amgen

An Open-label, Randomized, 2-period Crossover Bioequivalence Study Comparing a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection in the Thigh Using an Auto-injector Device and Manual Injection

A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection device to manual injection (each injection separated by 28 days)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A single-center, open-label, 2-period, 2-sequence, 2-treatment, randomized, crossover study. After a screening period of up to 21 days before dosing, 36 eligible men and women will be assigned to receive a 50-mg subcutaneous (SC) dose of etanercept administered by each of 2 methods of injection (Treatment A: administration by auto-injector device; and Treatment B: administration by manual injection) on separate occasions in an order determined by a randomization list (randomized 1:1 to sequence). Treatment administrations will be separated by a minimum of 28 days (maximum of 36 days). Subjects will be required to remain resident during the 72-hours after dosing in each period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women between the age of 18 and 45 years, inclusive at the time of screening
  • Body mass index (BMI) between 19 and 30 kg/m2, inclusive at the time of screening
  • Absence of clinically significant physical examination findings as determined by the investigator and free of any clinically significant disease or condition that requires care by a physician that would interfere with the study evaluation or procedures
  • 12-lead ECG (reporting ventricular rate and PR, QRS, QT and QTc intervals) within normal limits or clinically acceptable to the investigator
  • Negative human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody (HepCAb) status at the time of screening
  • Negative pregnancy test for all women at screening and the day before dosing
  • Willing to reside in the research facility for 3 consecutive nights, on two occasions, and willing to return to research facility for scheduled follow-up visits
  • Before any study specific procedures or administration of study medication, the subject must sign the Institutional Review Board (IRB)-approved informed consent form

Exclusion Criteria:

  • Unstable medical condition, defined as having been hospitalized within 30 days, myocardial infarction within 6 months, major surgery within 6 months, or a seizure within 12 months of study day 1, or otherwise unstable in the judgment of the investigator (i.e., at risk of complications or adverse events unrelated to study participation)
  • Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed at screening as determined by the investigator
  • Current active infection, including chronic or localized infection or history of recurring infections with underlying condition that may predispose one to infection (e.g., diabetes)
  • Known history of active tuberculosis
  • Donated blood or blood products within 12 weeks before day -1, or a total of 1500 mL within 1 year before day -1
  • Known hypersensitivity to etanercept or any excipients
  • Use of any prescription or over-the-counter medication within 7 days before day -1 without the approval of the investigator (with the exception of vitamins, topical medications, contraceptive medications, or hormonal replacement therapy in postmenopausal women)
  • Consumption of alcohol within 48 hours before dosing
  • Known history of drug or alcohol abuse within 1 year of screening
  • Positive urine screen for alcohol and/or potential drugs of abuse, at screening, and the day before dosing
  • Smoked more than 10 cigarettes per day within the 12 months before day -1
  • Women who are nursing or lactating
  • Unwilling or unable to practice an adequate barrier method of contraception (e.g., condom, barrier method contraceptive with spermicide, IUD, etc.), as determined by the investigator, for the duration of the study
  • Use of an investigational agent, drug, and/or device within 30 days of screening
  • Any other condition that might reduce the chance of obtaining data (e.g., known poor compliance) required by the protocol or that might compromise the ability to give informed consent

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Treatment A-etanercept (ENBREL®) via auto-injector device
Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL)
Device: etanercept (ENBREL®) via 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)
OTHER: Treatment B-etanercept (ENBREL®) via 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ratio of the geometric mean of etanercept (ENBREL®) administered by auto-injector Scandinavian Health Limited-SHL) to etanercept administered by manual injection for the pharmacokinetic (PK) parameter of AUC(0-t)
Time Frame: 28 days following each treatment arm
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. Blood samples are collected pre-dose and after dosing for both treatment periods.
28 days following each treatment arm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary includes the pharmokinetic parameter to measure the etanercept (ENBREL®) AUC (0-x), area under the curve
Time Frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
28 days after receiving treatment in Period 1, subjects return to facility to receive the alternate treatment in Period 2. Procedures performed in the first period are repeated in the second period. (Blood samples are collected pre-dose and after dosing for both treatment periods.)
28 days: timepoint at which outcome measure is assessed following each treatment arm
Safety Events measured by number of adverse events and retationship to treatment
Time Frame: 28 days following each treatment arm (total of 77 days including screening)
Number of adverse events for each subject summarized by system organ class, severity, and relationship to treatment
28 days following each treatment arm (total of 77 days including screening)
Any significant changes from baseline in Vital Signs and physical examinations
Time Frame: Baseline and 28 days following each treatment arm (total of 77 days including screening)
Change from baselline of vital signs, which includes blood pressure (systolic and diastolic) and heart rate per minute.
Baseline and 28 days following each treatment arm (total of 77 days including screening)
Any Clinically Significant changes in clinical laboratory tests will be noted.
Time Frame: Collected screening, Day -1 in both treatment periods, and day 15 in treatment period 2
Clinically significant abnormalities in clinical laboratory tests (chemistry and hematology and urine) analyzed by standard procedures
Collected screening, Day -1 in both treatment periods, and day 15 in treatment period 2
12-lead Electrocardiograms will be performed and saved with subject source records
Time Frame: Performed at screening and day 15 in Treatment B
Standard 12-lead electrocardiogram (ECG) with review of ventricular rate, rhythm, and interval measurements and appearance of the ECG waves will be performed
Performed at screening and day 15 in Treatment B
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 to measure seroreactivity to etanercept
Predose in each treatment period and 28 days following dosing in treatment period B
Secondary includes measure of pharmacokinetic parameter of Tmax, the time to reach maximum concentration
Time Frame: 28 days following each treatment period the outcome will be measured
Subjects return to the facility 28 days following each treatment segment (blood samples are collected immediately pre-dose and after dosing)
28 days following each treatment period the outcome will be measured
Secondary outcome to measure t 1/2: elimination half-life for etanercept
Time Frame: Outcome to be measured 28 days following each treatment
Subjects return to the facility 28 days following dosing; blood samples are taken immediately pre-dose and after treatment
Outcome to be measured 28 days following each treatment
Secondary to include etanercept pharmacokinetic parameter of CL/F: apparent clearance
Time Frame: Measurement assessed at 29 day timepoint following each treatment arm
Subjects return to facility 28 days following each treatment; blood sample is obtained immediately pre-dose and after dosing
Measurement assessed at 29 day timepoint following each treatment arm

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2004

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2004

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20040136

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.

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