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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-etanercept (ENBREL®) by auto-injector | Active Comparator | Single 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 | Other | Single dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Profile PK parameters of AUC (0-∞) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| 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 |
|
| Etanercept (ENBREL®) | Drug | 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) |
|
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 | 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 | 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 | 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 ) | 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) | 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) | terminal phase half-life | 28 days: timepoint at which outcome measure is assessed following each treatment arm |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |