Study Complete
Sponsor ID
20040136

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

Sponsor ID
20040136
Clinicaltrials.gov ID
NCT02588534
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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)

Additional Study Details

Phase
Phase 1
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
36
Additional Study Details

Protocol Summary

Primary Outcome Measures

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)

Timeframe: 28 days following each treatment arm

Secondary Outcome Measures

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

Timeframe: 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

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

Any significant changes from baseline in Vital Signs and physical examinations

Timeframe: 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.

Timeframe: 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

Timeframe: Performed at screening and day 15 in Treatment B

Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment

Timeframe: 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

Timeframe: 28 days following each treatment period the outcome will be measured

Secondary outcome to measure t 1/2: elimination half-life for etanercept

Timeframe: Outcome to be measured 28 days following each treatment

Secondary to include etanercept pharmacokinetic parameter of CL/F: apparent clearance

Timeframe: Measurement assessed at 29 day timepoint following each treatment arm

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.