Autoinjector Device Assessment Study

NCT02349802 | Completed Phase 1

• 1 other identifier: D5554C00001
• Study Type: interventional
• Target: 3,052
• Locations: 1 country
• Sites: 2

Brief Summary

Phase I study to determine the device-related injection failure rate of the single-use, pre-filled autoinjector.

Conditions

Healthy Subjects

Keywords

Auto-injector Device, device-related injection, Auto-injector

Outcome Measures

Primary Outcomes (1)

• 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.

  10 week study

Secondary Outcomes (1)

• Number of device-related injection failures of alternate device configuration

  10 week study

Study Arms (5)

Arm 1

EXPERIMENTAL

exenatide suspension - 9 mg / 0.85 mL

Drug: Auto-injector with exenatide suspension

Arm 2

EXPERIMENTAL

exenatide suspension - 9 mg / 0.85 mL

Drug: Syringe with exenatide suspension

Arm 3

EXPERIMENTAL

exenatide suspension - 4.5 mg /1.1 mL

Drug: Syringe with exenatide suspension

Arm 4

EXPERIMENTAL

exenatide suspension - 9 mg / 1.1 mL

Drug: Syringe with exenatide suspension

Arm 5

EXPERIMENTAL

exenatide suspension - 9 mg / 1.5 mL

Drug: Syringe with exenatide suspension

Interventions

Auto-injector with exenatide suspension DRUG

A flexible study design to accommodate multiple cohorts.

Arm 1

Syringe with exenatide suspension DRUG

A flexible study design to accommodate multiple cohorts.

Arm 2; Arm 3; Arm 4; Arm 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Celerion: collaborator

Study Sites (2)

Research Site

Tempe, Arizona, United States

Location

Research Site

Lincoln, Nebraska, United States

Location

Related Links

• D5554C00001\_CSR\_Synopsis

MeSH Terms

Interventions

Syringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Danielle Armas, MD

  Celerion

  PRINCIPAL INVESTIGATOR

• Peter Davidson, DO

  Celerion

  PRINCIPAL INVESTIGATOR

• Elise Hardy, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 2, 2015

Record last verified: 2015-01

Locations

US (2)