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

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Men and Women

Treatments: Drug: Etanercept (ENBREL®); Other: Etanercept (ENBREL®) via Manual injection; Device: Auto-injector device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02799498

20030121

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 patients

Sex

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

A-etanercept (ENBREL®) by auto-injector

Active Comparator group

Description:

Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL)

Treatment:

Drug: Etanercept (ENBREL®)

Device: Auto-injector device

B-etanercept (ENBREL®) by Manual injection

Other group

Description:

Single dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment)

Treatment:

Other: Etanercept (ENBREL®) via Manual injection