Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Hypoglycemia Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Glucagon for Injection (Eli Lilly) and GlucaGen® (Novo Nordisk) Administered by Subcutaneous and Intramuscular Injection in Normal, Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403648
• Other study ID #: 6-101
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2015
• Last updated: January 14, 2016
• Start date: November 2014

Study information

• Verified date: January 2016
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.

Description:

Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Body Mass Index: 18.5-25.0 kg/m2 inclusive.

• Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.

Exclusion Criteria:

• Type 1 or type 2 diabetes mellitus.

• History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.

• History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.

• Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.

• Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.

• Females who are breast feeding, pregnant, or intending to become pregnant during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• BIOD-961
BIOD-961 is a lyophilized glucagon formulation.
• Lilly Glucagon

• Novo Glucagon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon maximal concentration and area under curve		240 minutes post dose	No
Primary	Glucose maximal concentration and area under curve		240 minutes after dose	No
Secondary	Time to maximal glucagon concentration		240 minutes after dose	No
Secondary	Time to maximal glucose concentration		240 minutes after dose	No
Secondary	Maximal glucose excursion		240 minutes after dose	No
Secondary	Area under the glucose time curve from 0 to return to baseline after blood glucose peaked		240 minutes after dose	No