Healthy Men and WomenPhase 1NCT02588534
Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects
A Phase 1 study testing etanercept (ENBREL®) via auto-injector device and Etanercept (ENBREL®) via Manual injection in people with Healthy Men and Women, run by Amgen.
Trial summary
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection device to manual injection (each injection separated by 28 days) 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?
- etanercept (ENBREL®) via auto-injector device and Etanercept (ENBREL®) via Manual injection
- 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
- Aug 2004to Oct 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
- Men and women between the age of 18 and 45 years, inclusive at the time of screening
- Body mass index (BMI) between 19 and 30 kg/m2, inclusive at the time of screening
- Absence of clinically significant physical examination findings as determined by the investigator and free of any clinically significant disease or condition that requires care by a physician that would interfere with the study evaluation or procedures
- 12-lead ECG (reporting ventricular rate and PR, QRS, QT and QTc intervals) within normal limits or clinically acceptable to the investigator
- Negative human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody (HepCAb) status at the time of screening
- Negative pregnancy test for all women at screening and the day before dosing
- Willing to reside in the research facility for 3 consecutive nights, on two occasions, and willing to return to research facility for scheduled follow-up visits
- Before any study specific procedures or administration of study medication, the subject must sign the Institutional Review Board (IRB)-approved informed consent form
Who cannot join
- Unstable medical condition, defined as having been hospitalized within 30 days, myocardial infarction within 6 months, major surgery within 6 months, or a seizure within 12 months of study day 1, or otherwise unstable in the judgment of the investigator (i.e., at risk of complications or adverse events unrelated to study participation)
- Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed at screening as determined by the investigator
- Current active infection, including chronic or localized infection or history of recurring infections with underlying condition that may predispose one to infection (e.g., diabetes)
- Known history of active tuberculosis
- Donated blood or blood products within 12 weeks before day -1, or a total of 1500 mL within 1 year before day -1
- Known hypersensitivity to etanercept or any excipients
Show all 15Show fewer
- Use of any prescription or over-the-counter medication within 7 days before day -1 without the approval of the investigator (with the exception of vitamins, topical medications, contraceptive medications, or hormonal replacement therapy in postmenopausal women)
- Consumption of alcohol within 48 hours before dosing
- Known history of drug or alcohol abuse within 1 year of screening
- Positive urine screen for alcohol and/or potential drugs of abuse, at screening, and the day before dosing
- Smoked more than 10 cigarettes per day within the 12 months before day -1
- Women who are nursing or lactating
- Unwilling or unable to practice an adequate barrier method of contraception (e.g., condom, barrier method contraceptive with spermicide, IUD, etc.), as determined by the investigator, for the duration of the study
- Use of an investigational agent, drug, and/or device within 30 days of screening
- Any other condition that might reduce the chance of obtaining data (e.g., known poor compliance) required by the protocol or that might compromise the ability to give informed consent
About this study
Official title: An Open-label, Randomized, 2-period Crossover Bioequivalence Study Comparing a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection in the Thigh Using an Auto-injector Device and Manual Injection
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection device to manual injection (each injection separated by 28 days)
Read the detailed description
A single-center, open-label, 2-period, 2-sequence, 2-treatment, randomized, crossover study. After a screening period of up to 21 days before dosing, 36 eligible men and women will be assigned to receive a 50-mg subcutaneous (SC) dose of etanercept administered by each of 2 methods of injection (Treatment A: administration by auto-injector device; and Treatment B: administration by manual injection) on separate occasions in an order determined by a randomization list (randomized 1:1 to sequence). Treatment administrations will be separated by a minimum of 28 days (maximum of 36 days). Subjects will be required to remain resident during the 72-hours after dosing in each period.
- Conditions
- Healthy Men and Women
- Being tested
- etanercept (ENBREL®) via auto-injector device, Etanercept (ENBREL®) via Manual injection
- Keywords
- etanercept, healthy subject,open-label, randomized, auto-injection, bioequivalence, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanercept (ENBREL®) via 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-etanercept (ENBREL®) via auto-injector device | 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: etanercept (ENBREL®) via auto-injector device |
| Treatment B-etanercept (ENBREL®) via 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 mean of etanercept (ENBREL®) administered by auto-injector Scandinavian Health Limited-SHL) to etanercept administered by manual injection for the pharmacokinetic (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. Blood samples are collected pre-dose and after dosing for both treatment periods.
Measured: 28 days following each treatment arm
Secondary outcomes (9)
Secondary includes the pharmokinetic parameter to measure the etanercept (ENBREL®) AUC (0-x), area under the curve
28 days after receiving treatment in Period 1, subjects return to facility to receive the alternate treatment in Period 2. Procedures performed in the first period are repeated in the second period. (Blood samples are collected pre-dose and after dosing for both treatment periods.)
Measured: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Safety Events measured by number of adverse events and retationship to treatment
Number of adverse events for each subject summarized by system organ class, severity, and relationship to treatment
Measured: 28 days following each treatment arm (total of 77 days including screening)
Any significant changes from baseline in Vital Signs and physical examinations
Change from baselline of vital signs, which includes blood pressure (systolic and diastolic) and heart rate per minute.
Measured: Baseline and 28 days following each treatment arm (total of 77 days including screening)
Any Clinically Significant changes in clinical laboratory tests will be noted.
Clinically significant abnormalities in clinical laboratory tests (chemistry and hematology and urine) analyzed by standard procedures
Measured: Collected screening, Day -1 in both treatment periods, and day 15 in treatment period 2
12-lead Electrocardiograms will be performed and saved with subject source records
Standard 12-lead electrocardiogram (ECG) with review of ventricular rate, rhythm, and interval measurements and appearance of the ECG waves will be performed
Measured: Performed at screening and day 15 in Treatment B
Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment
Blood samples to measure seroreactivity to etanercept
Measured: Predose in each treatment period and 28 days following dosing in treatment period B
Secondary includes measure of pharmacokinetic parameter of Tmax, the time to reach maximum concentration
Subjects return to the facility 28 days following each treatment segment (blood samples are collected immediately pre-dose and after dosing)
Measured: 28 days following each treatment period the outcome will be measured
Secondary outcome to measure t 1/2: elimination half-life for etanercept
Subjects return to the facility 28 days following dosing; blood samples are taken immediately pre-dose and after treatment
Measured: Outcome to be measured 28 days following each treatment
Secondary to include etanercept pharmacokinetic parameter of CL/F: apparent clearance
Subjects return to facility 28 days following each treatment; blood sample is obtained immediately pre-dose and after dosing
Measured: Measurement assessed at 29 day timepoint 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 posted28 Oct 2015 (estimated)
- Study startAug 2004
- Primary completionOct 2004
- Study completionOct 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
- NCT02588534
- Sponsor's protocol ID
- 20040136
- Status last verified
- Oct 2015
- First submitted
- 18 Jun 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2-period Crossover Bioequivalence Study Comparing a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection in the Thigh Using an Auto-injector Device and Manual Injection
- ClinicalTrials.gov ID
- NCT02588534
- Acronym / sponsor ID
- 20040136
- Conditions
- Healthy Men and Women
- Keywords
- etanercept, healthy subject,open-label, randomized, auto-injection, bioequivalence, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 28 Oct 2015 (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.
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection device to manual injection (each injection separated by 28 days)
Detailed description
A single-center, open-label, 2-period, 2-sequence, 2-treatment, randomized, crossover study. After a screening period of up to 21 days before dosing, 36 eligible men and women will be assigned to receive a 50-mg subcutaneous (SC) dose of etanercept administered by each of 2 methods of injection (Treatment A: administration by auto-injector device; and Treatment B: administration by manual injection) on separate occasions in an order determined by a randomization list (randomized 1:1 to sequence). Treatment administrations will be separated by a minimum of 28 days (maximum of 36 days). Subjects will be required to remain resident during the 72-hours after dosing in each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A-etanercept (ENBREL®) via auto-injector device | Active comparator | Device: etanercept (ENBREL®) via auto-injector deviceSingle dose of etanercept (ENBREL®) in a pre-filled syringe administered with an auto-injector device manufactured by Scandinavian Health Limited (SHL) |
| Treatment B-etanercept (ENBREL®) via 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 (8 listed)
- Men and women between the age of 18 and 45 years, inclusive at the time of screening
- Body mass index (BMI) between 19 and 30 kg/m2, inclusive at the time of screening
- Absence of clinically significant physical examination findings as determined by the investigator and free of any clinically significant disease or condition that requires care by a physician that would interfere with the study evaluation or procedures
- 12-lead ECG (reporting ventricular rate and PR, QRS, QT and QTc intervals) within normal limits or clinically acceptable to the investigator
- Negative human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody (HepCAb) status at the time of screening
Key exclusion criteria (15 listed)
- Unstable medical condition, defined as having been hospitalized within 30 days, myocardial infarction within 6 months, major surgery within 6 months, or a seizure within 12 months of study day 1, or otherwise unstable in the judgment of the investigator (i.e., at risk of complications or adverse events unrelated to study participation)
- Clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed at screening as determined by the investigator
- Current active infection, including chronic or localized infection or history of recurring infections with underlying condition that may predispose one to infection (e.g., diabetes)
- Known history of active tuberculosis
- Donated blood or blood products within 12 weeks before day -1, or a total of 1500 mL within 1 year before day -1
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 |
|---|---|---|
| etanercept (ENBREL®) via 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 | Treatment A-etanercept (ENBREL®) via auto-injector device |
| 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 | Treatment B-etanercept (ENBREL®) via Manual injection |
Primary outcome
Ratio of the geometric mean of etanercept (ENBREL®) administered by auto-injector Scandinavian Health Limited-SHL) to etanercept administered by manual injection for the pharmacokinetic (PK) parameter of AUC(0-t)
Time frame: 28 days following each treatment arm
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. Blood samples are collected pre-dose and after dosing for both treatment periods.
9 secondary outcomes
Secondary includes the pharmokinetic parameter to measure the etanercept (ENBREL®) AUC (0-x), area under the curve
Time frame: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Safety Events measured by number of adverse events and retationship to treatment
Time frame: 28 days following each treatment arm (total of 77 days including screening)
Any significant changes from baseline in Vital Signs and physical examinations
Time frame: Baseline and 28 days following each treatment arm (total of 77 days including screening)
Any Clinically Significant changes in clinical laboratory tests will be noted.
Time frame: Collected screening, Day -1 in both treatment periods, and day 15 in treatment period 2
12-lead Electrocardiograms will be performed and saved with subject source records
Time frame: Performed at screening and day 15 in Treatment B
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
Secondary includes measure of pharmacokinetic parameter of Tmax, the time to reach maximum concentration
Time frame: 28 days following each treatment period the outcome will be measured
Secondary outcome to measure t 1/2: elimination half-life for etanercept
Time frame: Outcome to be measured 28 days following each treatment
Secondary to include etanercept pharmacokinetic parameter of CL/F: apparent clearance
Time frame: Measurement assessed at 29 day timepoint 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 28 Oct 2015.
- 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 etanercept (ENBREL®) via auto-injector device and Etanercept (ENBREL®) via Manual injection 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 8 inclusion and 15 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 28 Oct 2015. 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 mean of etanercept (ENBREL®) administered by auto-injector Scandinavian Health Limited-SHL) to etanercept administered by manual injection for the pharmacokinetic (PK) parameter of AUC(0-t) (time frame: 28 days following each treatment arm). 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 28 Oct 2015.