Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection

Healthy Men and Women Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799498
• Other study ID #: 20030121
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2015
• Last updated: June 9, 2016
• Start date: October 2003
• Est. completion date: January 2004

Study information

• Verified date: June 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Men and Women

Intervention

Device:
• Auto-injector 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)

Other:
• Etanercept (ENBREL®) via Manual injection
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

Drug:
• Etanercept (ENBREL®)
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Profile PK parameters of AUC (0-8)	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	No
Secondary	Safety Events measured by adverse events and how they relate to study drug	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Profile PK parameters of AUC (C max )	maximum observed concentration	28 days: timepoint at which outcome measure is assessed following each treatment arm	No
Secondary	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	No
Secondary	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	No

External Links

•   AmgenTrials clinical trials website