Clinical trial NCT02403648: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypoglycemia
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Glucagon maximal concentration and area under curve
timeFrame: 240 minutes post dose
measure: Glucose maximal concentration and area under curve
timeFrame: 240 minutes after dose
Secondary outcomes:
measure: Time to maximal glucagon concentration
timeFrame: 240 minutes after dose
measure: Time to maximal glucose concentration
timeFrame: 240 minutes after dose
measure: Maximal glucose excursion
timeFrame: 240 minutes after dose
measure: Area under the glucose time curve from 0 to return to baseline after blood glucose peaked
timeFrame: 240 minutes after dose
Other outcomes:
Locations:
Study officials:
affiliation: Profil Institute for Clinical Research, Inc.
name: Linda Morrow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biodel
name: Alan Krasner, MD
role: STUDY_DIRECTOR
References: