Healthy Men and WomenPhase 1NCT02799498
Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection
A Phase 1 study testing Auto-injector device, Etanercept (ENBREL®) via Manual injection and Etanercept (ENBREL®) in people with Healthy Men and Women, run by Amgen.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- Auto-injector device, Etanercept (ENBREL®) via Manual injection and Etanercept (ENBREL®)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Jan 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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/
Show all 10Show fewer
- 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
About this study
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
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).
Read the 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.
- Conditions
- Healthy Men and Women
- Being tested
- Auto-injector device, Etanercept (ENBREL®) via Manual injection, Etanercept (ENBREL®)
- Keywords
- etanercept, healthy subject, open-label, randomized, PK, auto-injection, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-injector deviceDevice
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 injectionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| A-etanercept (ENBREL®) by auto-injector | Active comparator | Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL) Receives: Device: Auto-injector device; Drug: Etanercept (ENBREL®) |
| B-etanercept (ENBREL®) by Manual injection | Other | Single dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment) Receives: Other: Etanercept (ENBREL®) via Manual injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (8)
Profile PK parameters of AUC (0-∞)
PK parameters of the area under the serum drug concentration-time curve from time zero to infinity
Measured: 28 days: timepoint at which outcome measure is assessed following each treatment arm
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
Measured: 28 days-timepoint at which outcome measure is assessed following each treatment arm
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
Measured: Baseline and 28 days following each treatment
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
Measured: Collected at screening, Day -1, Day 4 after dosing each treatment period, and on day 15 after dosing in Period 2
Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment
Blood samples collected to measure seroreactivity to etanercept
Measured: Predose in each treatment period and 28 days following dosing in treatment period B
Profile PK parameters of AUC (C max )
maximum observed concentration
Measured: 28 days: timepoint at which outcome measure is assessed following each treatment arm
PK parameters of the area under the serum drug concentration (t 1/2)
terminal phase half-life
Measured: 28 days: timepoint at which outcome measure is assessed following each treatment arm
PK parameters of the area under the serum drug concentration (t z)
terminal phase half-life
Measured: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startOct 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799498
- Sponsor's protocol ID
- 20030121
- Status last verified
- Jun 2016
- First submitted
- 4 Jun 2015
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02799498
- Acronym / sponsor ID
- 20030121
- Conditions
- Healthy Men and Women
- Keywords
- etanercept, healthy subject, open-label, randomized, PK, auto-injection, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-etanercept (ENBREL®) by auto-injector | Active comparator | Device: Auto-injector device, Drug: Etanercept (ENBREL®)Single dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL) |
| B-etanercept (ENBREL®) by Manual injection | Other | Other: Etanercept (ENBREL®) via Manual injectionSingle dose of etanercept (ENBREL®) in a syringe given by manual injection (reference treatment) |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-injector deviceSingle 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) | Device | A-etanercept (ENBREL®) by auto-injector |
| Etanercept (ENBREL®) via Manual injectionSingle 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 | Other | B-etanercept (ENBREL®) by Manual injection |
| 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) | Drug | A-etanercept (ENBREL®) by auto-injector |
Primary outcome
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.
8 secondary outcomes
Profile PK parameters of AUC (0-∞)
Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
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
Measure of vital signs changes from baseline to end of each treatment period
Time frame: Baseline and 28 days following each treatment
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
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
Profile PK parameters of AUC (C max )
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 (t 1/2)
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 (t z)
Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Auto-injector device, Etanercept (ENBREL®) via Manual injection and Etanercept (ENBREL®) in people with Healthy Men and Women, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.