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)
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
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.
Time frame: 28 days following each treatment arm
Secondary includes the pharmokinetic parameter to measure the etanercept (ENBREL®) AUC (0-x), area under the curve
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.)
Time frame: 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
Number of adverse events for each subject summarized by system organ class, severity, and relationship to treatment
Time frame: 28 days following each treatment arm (total of 77 days including screening)
Any significant changes from baseline in Vital Signs and physical examinations
Change from baselline of vital signs, which includes blood pressure (systolic and diastolic) and heart rate per minute.
Time frame: 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.
Clinically significant abnormalities in clinical laboratory tests (chemistry and hematology and urine) analyzed by standard procedures
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Time frame: 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
Standard 12-lead electrocardiogram (ECG) with review of ventricular rate, rhythm, and interval measurements and appearance of the ECG waves will be performed
Time frame: Performed at screening and day 15 in Treatment B
Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment
Blood samples to measure seroreactivity to etanercept
Time frame: 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
Subjects return to the facility 28 days following each treatment segment (blood samples are collected immediately pre-dose and after dosing)
Time frame: 28 days following each treatment period the outcome will be measured
Secondary outcome to measure t 1/2: elimination half-life for etanercept
Subjects return to the facility 28 days following dosing; blood samples are taken immediately pre-dose and after treatment
Time frame: Outcome to be measured 28 days following each treatment
Secondary to include etanercept pharmacokinetic parameter of CL/F: apparent clearance
Subjects return to facility 28 days following each treatment; blood sample is obtained immediately pre-dose and after dosing
Time frame: Measurement assessed at 29 day timepoint following each treatment arm