Autoinjector Device Assessment Study - BCB119

Study identifier:D5554C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Evaluation of the Single-Use Pre-Filled Autoinjector

Medical condition

Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Auto-injector with exenatide suspension, Syringe with exenatide suspension

Sex

All

Actual Enrollment

3052

Study type

Interventional

Age

18 Years - 100 Years

Date

Study Start Date: 01 Feb 2013

Primary Completion Date: 01 Dec 2013

Study Completion Date: 01 Dec 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by AstraZeneca

Collaborators

Celerion, Inc

Inclusion and exclusion criteria

Inclusion Criteria

- 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:
a. Not breastfeeding
b. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [bhCG]) at Visit 1
(Screening)
c. 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

Exclusion Criteria

- 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:
a. History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations
≥500 mg/dL at Visit 1 (Screening)
b. Presence of medullary carcinoma or multiple endocrine neoplasia (MEN II) OR a family history
of medullary carcinoma or MEN II
c. Organ transplantation
d. 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.
e. Presence or history of severe congestive heart failure (New York Heart Association Class IV
[CCNYHA 1994])
f. Central nervous system disease, including epilepsy (individuals with a history of convulsions
associated with hypoglycemia will not be excluded)
g. 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
h. 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
i. Clinically significant malignant disease (with the exception of basal and squamous cell
carcinoma of the skin) within 5 years of Visit 1 (Screening)
j. Hemoglobinopathy, hemolytic anemia, or anemia (hemoglobin concentration below the lower
limit of normal unless deemed not clinically significant by the investigator)
k. 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
l. 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)

No locations available

Arms	Assigned Interventions
Experimental: Arm 1 exenatide suspension - 9 mg / 0.85 mL	Drug: Auto-injector with exenatide suspension A flexible study design to accommodate multiple cohorts.
Experimental: Arm 2 exenatide suspension - 9 mg / 0.85 mL	Drug: Syringe with exenatide suspension A flexible study design to accommodate multiple cohorts.
Experimental: Arm 3 exenatide suspension - 4.5 mg /1.1 mL	Drug: Syringe with exenatide suspension A flexible study design to accommodate multiple cohorts.
Experimental: Arm 4 exenatide suspension - 9 mg / 1.1 mL	Drug: Syringe with exenatide suspension A flexible study design to accommodate multiple cohorts.
Experimental: Arm 5 exenatide suspension - 9 mg / 1.5 mL	Drug: Syringe with exenatide suspension A flexible study design to accommodate multiple cohorts.

Documents available

D5554C00001_CSR_Synopsis
Download

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Danielle Armas