Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia
• Intervention / Treatment: Drug: BIOD-961; Drug: Lilly Glucagon; Drug: Novo Glucagon

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIOD-961, 1 mg IM; Intramuscular delivery of BIOD-961.	Drug: BIOD-961; BIOD-961 is a lyophilized glucagon formulation.
Active Comparator: Lilly Glucagon, 1 mg IM; Intramuscular delivery of Lilly glucagon.	Drug: Lilly Glucagon
Active Comparator: Novo Glucagon, 1 mg IM; Intramuscular delivery of Novo glucagon.	Drug: Novo Glucagon
Experimental: BIOD-961, 1 mg SC; Subcutaneous delivery of BIOD-961,	Drug: BIOD-961; BIOD-961 is a lyophilized glucagon formulation.
Active Comparator: Lilly Glucagon, 1 mg SC; Subcutaneous delivery of Lilly glucagon.	Drug: Lilly Glucagon
Active Comparator: Novo Glucagon, 1 mg SC; Subcutaneous delivery of Novo glucagon.	Drug: Novo Glucagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucagon maximal concentration and area under curve	240 minutes post dose
Glucose maximal concentration and area under curve	240 minutes after dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximal glucagon concentration	240 minutes after dose
Time to maximal glucose concentration	240 minutes after dose
Maximal glucose excursion	240 minutes after dose
Area under the glucose time curve from 0 to return to baseline after blood glucose peaked	240 minutes after dose

Collaborators and Investigators

• Sponsor: Biodel
• Investigators: Principal Investigator: Linda Morrow, MD, Profil Institute for Clinical Research, Inc.; Study Director: Alan Krasner, MD, Biodel

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): January 15, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: 6-101