Clinical trial NCT02799498: Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection
Official title: An Open-label, Randomized, 2-period Crossover Study to Compare the Pharmacokinetics of a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection Using an Auto-Injector Device and Manual Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Men and Women
Keywords: etanercept
healthy subject
open-label
randomized
PK
auto-injection
pharmacokinetic
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healty men and women
* Aged 18-55 years at time of screening
* BMI 18-31 kg/m2 inclusive
* Free of any clinically significant disease
* Willing to reside in research facility 4 consecutive nights 2 times and to attend follow up visits
* Willing to sign consent
* Negative HIV, hepatitis B and C, and urine pregnancy tests

Exclusion Criteria:

* Unstable medical condition (hospitalized within 30 days, myocardial infarction or major surgery within 6 months, or seizure within 12 months of study day 1)
* Current active infecton, history of infections, or condition which may predispose infection (such as diabetes)
* Clinically significant abnormality in laboratory samples done while screening
* history of tuberculosis
* donated blood within 30 days of screening
* Use of prescription or over-the-counter medication during the study/
* History of smoking or use of tobacco within 30 days of screening
* Positive urine scree for alcohol or drugs of abuse at screening or the day prior to dosing
* Unwilling to pracitce contraception for the duration ot the study
* Any other condition which could interfere with obtaining data required by the protocol

Primary outcomes:
measure: Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)
timeFrame: 28 days
Secondary outcomes:
measure: Profile PK parameters of AUC (0-∞)
timeFrame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
measure: Safety Events measured by adverse events and how they relate to study drug
timeFrame: 28 days-timepoint at which outcome measure is assessed following each treatment arm
measure: Measure of vital signs changes from baseline to end of each treatment period
timeFrame: Baseline and 28 days following each treatment
measure: Any Clinically Significant changes in clinical laboratory tests will be noted
timeFrame: Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2
measure: 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
measure: Profile PK parameters of AUC (C max )
timeFrame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
measure: PK parameters of the area under the serum drug concentration (t 1/2)
timeFrame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
measure: PK parameters of the area under the serum drug concentration (t z)
timeFrame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: