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

NCT02588534 | Completed Phase 1

• 1 other identifier: 20040136
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Healthy Men and Women

Keywords

etanercept, healthy subject,open-label, randomized, auto-injection, bioequivalence, pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (9)

• Secondary includes the pharmokinetic parameter to measure the etanercept (ENBREL®) AUC (0-x), area under the curve

  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

  28 days following each treatment arm (total of 77 days including screening)

• Any significant changes from baseline in Vital Signs and physical examinations

  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.

  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

  Performed at screening and day 15 in Treatment B

Study Arms (2)

Treatment A-etanercept (ENBREL®) via auto-injector device

ACTIVE COMPARATOR

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

Treatment B-etanercept (ENBREL®) via Manual injection

OTHER

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

Other: Etanercept (ENBREL®) via Manual injection

Interventions

etanercept (ENBREL®) via auto-injector device 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)

Treatment A-etanercept (ENBREL®) via auto-injector device

Etanercept (ENBREL®) via Manual injection 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

Treatment B-etanercept (ENBREL®) via Manual injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

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 18, 2015
• First Posted: October 28, 2015
• Study Start: August 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: October 28, 2015

Record last verified: 2015-10