Healthy SubjectsPhase 1BCB119NCT02349802
Autoinjector Device Assessment Study
A Phase 1 study testing Auto-injector with exenatide suspension and Syringe with exenatide suspension in people with Healthy Subjects, run by AstraZeneca at 2 sites in United States.
Trial summary
Phase I study to determine the device-related injection failure rate of the single-use, pre-filled autoinjector. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Auto-injector with exenatide suspension and Syringe with exenatide suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,052 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Dec 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 18 years old at Visit 1 (Screening). Subjects must be of legal age of consent.
- Has no significant health issues that would preclude study participation, as determined by medical history and physical examination
- Has body mass index of 22 kg/m2 to 45 kg/m2, inclusive, at Visit 1 (Screening)
- Has normal renal function (creatinine clearance adjusted for body surface area ≥90 mL/min/1.73 m2 as calculated using the MDRD equation) at Visit 1 (Screening)
- Is male, or is female and meets all the following criteria:
- Not breastfeeding
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- Negative pregnancy test result (human chorionic gonadotropin, beta subunit [bhCG]) at Visit 1 (Screening)
- If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation or occlusion, or a vasectomized partner) during the entire duration of the study. Subjects must practice appropriate birth control as stated above for 10 weeks after the last dose of study drug.
- Has no clinically significant abnormal laboratory test values (clinical chemistry, hematology, urinalysis) as judged by the investigator at Visit 1 (Screening)
- Has a physical examination and electrocardiogram (ECG) with no clinically significant abnormality, as judged by the investigator, at Screening
- Is able to read, understand, and sign the Informed Consent Forms (ICFs) and, if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements
Who cannot join
- Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
- History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations
- 500 mg/dL at Visit 1 (Screening)
- Presence of medullary carcinoma or multiple endocrine neoplasia (MEN II) OR a family history of medullary carcinoma or MEN II
- Organ transplantation
- Active cardiovascular disease within 3 months of Visit 1 such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study. Subjects with stable cardiac disease are not excluded.
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- Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994])
- Central nervous system disease, including epilepsy (individuals with a history of convulsions associated with hypoglycemia will not be excluded)
- Liver disease, acute or chronic hepatitis, alanine aminotransaminase (ALT), or serum glutamic pyruvic transaminase (SGPT) greater than 3 times the upper limit of the reference range
- History or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis, pyloric stenosis, gastric bypass surgery or gastric banding surgery
- Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
- Hemoglobinopathy, hemolytic anemia, or anemia (hemoglobin concentration below the lower limit of normal unless deemed not clinically significant by the investigator)
- Two or more episodes of severe hypoglycemia within 6 months prior to Visit 1. Refer to Section 9.1.5.2 for more information on hypoglycemia
- Evidence of acute or chronic illness including known or suspected human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) infection
- Has any abdominal skin abnormalities (e.g., extensive scarring, burns, inflammation, hyperkeratosis, etc.) which, in the investigator's opinion, could interfere with the injection.
- Has serum calcitonin concentration ≥100 pg/mL at Visit 1 (Screening)
- Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant
- Has a positive urine drug screen (including screen for cocaine, opiates, amphetamines, and cannabinoids)
- Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to Visit 1 (Screening)
- Has donated blood or had a significant blood loss within 2 months of first dose of study drug or is planning to donate blood during the study
- Has had a major surgery or a blood transfusion within 2 months prior to Visit 1 (Screening)
- Has known contraindication, allergies, or hypersensitivity to any component of study drug (including poly-D,L lactide co-glycolide [PLG] and MCT)
- Is employed by Amylin, Alkermes, Bristol-Myers Squibb, or AstraZeneca (i.e. that is an employee, temporary contract worker, or designee responsible for the conduct of the study)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Lincoln, Nebraska
Research Site
Tempe, Arizona
About this study
Official title: Evaluation of the Single-Use Pre-Filled Autoinjector
Phase I study to determine the device-related injection failure rate of the single-use, pre-filled autoinjector.
Read the detailed description
Phase I multi-cohort study will employ a flexible study design to accommodate multiple cohorts. Healthy male or female subjects >or= 18 years with no significant health issues will be included. Each cohort will employ an open-label, single-arm, repeat-dose design. Injection failure rates will be continually assessed. Injection pain will also be assessed.
- Conditions
- Healthy Subjects
- Being tested
- Auto-injector with exenatide suspension, Syringe with exenatide suspension
- Keywords
- Auto-injector Device, device-related injection, Auto-injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-injector with exenatide suspensionDrug
A flexible study design to accommodate multiple cohorts.
Syringe with exenatide suspensionDrug
A flexible study design to accommodate multiple cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | exenatide suspension - 9 mg / 0.85 mL Receives: Drug: Auto-injector with exenatide suspension |
| Arm 2 | Experimental | exenatide suspension - 9 mg / 0.85 mL Receives: Drug: Syringe with exenatide suspension |
| Arm 3 | Experimental | exenatide suspension - 4.5 mg /1.1 mL Receives: Drug: Syringe with exenatide suspension |
| Arm 4 | Experimental | exenatide suspension - 9 mg / 1.1 mL Receives: Drug: Syringe with exenatide suspension |
| Arm 5 | Experimental | exenatide suspension - 9 mg / 1.5 mL Receives: Drug: Syringe with exenatide suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of device-related failure injections
The primary outcome measure is the number of device-related injection failures of the single-use, pre-filled auto-injector.
Measured: 10 week study
Secondary outcomes (1)
Number of device-related injection failures of alternate device configuration
The secondary outcome measure is the number of device-related injection failures of alternate device configuration.
Measured: 10 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, MD, Principal investigator, CelerionPeter Davidson, DO, Principal investigator, CelerionElise Hardy, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349802
- Sponsor's protocol ID
- D5554C00001
- Acronym
- BCB119
- Status last verified
- Jan 2015
- First submitted
- 26 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Single-Use Pre-Filled Autoinjector
- ClinicalTrials.gov ID
- NCT02349802
- Acronym / sponsor ID
- BCB119 / D5554C00001
- Conditions
- Healthy Subjects
- Keywords
- Auto-injector Device, device-related injection, Auto-injector
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,052 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jan 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.
Phase I study to determine the device-related injection failure rate of the single-use, pre-filled autoinjector.
Detailed description
Phase I multi-cohort study will employ a flexible study design to accommodate multiple cohorts. Healthy male or female subjects >or= 18 years with no significant health issues will be included. Each cohort will employ an open-label, single-arm, repeat-dose design. Injection failure rates will be continually assessed. Injection pain will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Auto-injector with exenatide suspensionexenatide suspension - 9 mg / 0.85 mL |
| Arm 2 | Experimental | Drug: Syringe with exenatide suspensionexenatide suspension - 9 mg / 0.85 mL |
| Arm 3 | Experimental | Drug: Syringe with exenatide suspensionexenatide suspension - 4.5 mg /1.1 mL |
| Arm 4 | Experimental | Drug: Syringe with exenatide suspensionexenatide suspension - 9 mg / 1.1 mL |
| Arm 5 | Experimental | Drug: Syringe with exenatide suspensionexenatide suspension - 9 mg / 1.5 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is at least 18 years old at Visit 1 (Screening). Subjects must be of legal age of consent.
- Has no significant health issues that would preclude study participation, as determined by medical history and physical examination
- Has body mass index of 22 kg/m2 to 45 kg/m2, inclusive, at Visit 1 (Screening)
- Has normal renal function (creatinine clearance adjusted for body surface area ≥90 mL/min/1.73 m2 as calculated using the MDRD equation) at Visit 1 (Screening)
- Is male, or is female and meets all the following criteria:
Key exclusion criteria (23 listed)
- Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
- Has any abdominal skin abnormalities (e.g., extensive scarring, burns, inflammation, hyperkeratosis, etc.) which, in the investigator's opinion, could interfere with the injection.
- Has serum calcitonin concentration ≥100 pg/mL at Visit 1 (Screening)
- Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant
- Has a positive urine drug screen (including screen for cocaine, opiates, amphetamines, and cannabinoids)
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 with exenatide suspensionA flexible study design to accommodate multiple cohorts. | Drug | Arm 1 |
| Syringe with exenatide suspensionA flexible study design to accommodate multiple cohorts. | Drug | Arm 2, Arm 3, Arm 4, Arm 5 |
Primary outcome
Number of device-related failure injections
Time frame: 10 week study
The primary outcome measure is the number of device-related injection failures of the single-use, pre-filled auto-injector.
1 secondary outcome
Number of device-related injection failures of alternate device configuration
Time frame: 10 week study
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 2 Feb 2015.
- D5554C00001\_CSR\_SynopsisLink 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.
Danielle Armas, MD principal investigator
Celerion
Peter Davidson, DO principal investigator
Celerion
Elise Hardy, MD study director
AstraZeneca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Auto-injector with exenatide suspension and Syringe with exenatide suspension in people with Healthy Subjects, run by AstraZeneca at 2 sites in United States.
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 11 inclusion and 23 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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of device-related failure injections (time frame: 10 week study). 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 2 Feb 2015.