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Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

Primary Purpose

Hypoglycemia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

BIOD-961

Lilly Glucagon

Novo Glucagon

About this trial

This is an interventional treatment trial for Hypoglycemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

BIOD-961, 1 mg IM

Lilly Glucagon, 1 mg IM

Novo Glucagon, 1 mg IM

BIOD-961, 1 mg SC

Lilly Glucagon, 1 mg SC

Novo Glucagon, 1 mg SC

Arm Description

Intramuscular delivery of BIOD-961.

Intramuscular delivery of Lilly glucagon.

Intramuscular delivery of Novo glucagon.

Subcutaneous delivery of BIOD-961,

Subcutaneous delivery of Lilly glucagon.

Subcutaneous delivery of Novo glucagon.

Outcomes

Primary Outcome Measures

Glucagon maximal concentration and area under curve

Glucose maximal concentration and area under curve

Secondary Outcome Measures

Time to maximal glucagon concentration

Time to maximal glucose concentration

Maximal glucose excursion

Area under the glucose time curve from 0 to return to baseline after blood glucose peaked

Full Information

NCT ID

NCT02403648

First Posted

March 26, 2015

Last Updated

January 14, 2016

Sponsor

Biodel

1. Study Identification

Unique Protocol Identification Number

NCT02403648

Brief Title

Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biodel

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIOD-961, 1 mg IM

Arm Type

Experimental

Arm Description

Intramuscular delivery of BIOD-961.

Arm Title

Lilly Glucagon, 1 mg IM

Arm Type

Active Comparator

Arm Description

Intramuscular delivery of Lilly glucagon.

Arm Title

Novo Glucagon, 1 mg IM

Arm Type

Active Comparator

Arm Description

Intramuscular delivery of Novo glucagon.

Arm Title

BIOD-961, 1 mg SC

Arm Type

Experimental

Arm Description

Subcutaneous delivery of BIOD-961,

Arm Title

Lilly Glucagon, 1 mg SC

Arm Type

Active Comparator

Arm Description

Subcutaneous delivery of Lilly glucagon.

Arm Title

Novo Glucagon, 1 mg SC

Arm Type

Active Comparator

Arm Description

Subcutaneous delivery of Novo glucagon.

Intervention Type

Drug

Intervention Name(s)

BIOD-961

Intervention Description

BIOD-961 is a lyophilized glucagon formulation.

Intervention Type

Drug

Intervention Name(s)

Lilly Glucagon

Intervention Type

Drug

Intervention Name(s)

Novo Glucagon

Primary Outcome Measure Information:

Title

Glucagon maximal concentration and area under curve

Time Frame

240 minutes post dose

Title

Glucose maximal concentration and area under curve

Time Frame

240 minutes after dose

Secondary Outcome Measure Information:

Title

Time to maximal glucagon concentration

Time Frame

240 minutes after dose

Title

Time to maximal glucose concentration

Time Frame

240 minutes after dose

Title

Maximal glucose excursion

Time Frame

240 minutes after dose

Title

Area under the glucose time curve from 0 to return to baseline after blood glucose peaked

Time Frame

240 minutes after dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Morrow, MD

Organizational Affiliation

Profil Institute for Clinical Research, Inc.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alan Krasner, MD

Organizational Affiliation

Biodel

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

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