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OpenTrials
Completed

NCT Number: NCT02799498

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

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).

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Key information

Conditions

Healthy Men and Women

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Ratio of the geometric means of etanercept by auto-injector to etanercept by manual injection for the PK parameter of AUC (0-t)

    Time frame: 28 days

    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.

Secondary outcomes

  1. Profile PK parameters of AUC (0-∞)

    Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm

    PK parameters of the area under the serum drug concentration-time curve from time zero to infinity

  2. Safety Events measured by adverse events and how they relate to study drug

    Time frame: 28 days-timepoint at which outcome measure is assessed following each treatment arm

    Incidence, severity, and relationship to study drug of adverse events for each subject

  3. Measure of vital signs changes from baseline to end of each treatment period

    Time frame: Baseline and 28 days following each treatment

    Changes from baseline in vital signs (includes blood pressure-systolic and diastolic; and heart rate per minute) and physical examinations

  4. Any Clinically Significant changes in clinical laboratory tests will be noted

    Time frame: Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2

    Laboratory variables summarized separately from adverse events and compared to normal ranges; samples will be analyzed by standard procedures

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

    Time frame: Predose in each treatment period and 28 days following dosing in treatment period B

    Blood samples collected to measure seroreactivity to etanercept

  6. Profile PK parameters of AUC (C max )

    Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm

    maximum observed concentration

  7. PK parameters of the area under the serum drug concentration (t 1/2)

    Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm

    terminal phase half-life

  8. PK parameters of the area under the serum drug concentration (t z)

    Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm

    terminal phase half-life

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 15, 2016
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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