Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons
Information source: Biodel
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoglycemia
Intervention: BIOD-961 (Drug); Lilly Glucagon (Drug); Novo Glucagon (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Biodel Official(s) and/or principal investigator(s): Linda Morrow, MD, Principal Investigator, Affiliation: Profil Institute for Clinical Research, Inc. Alan Krasner, MD, Study Director, Affiliation: Biodel
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Glucagon maximal concentration and area under curveGlucose maximal concentration and area under curve
Secondary outcome: Time to maximal glucagon concentrationTime to maximal glucose concentration Maximal glucose excursion Area under the glucose time curve from 0 to return to baseline after blood glucose peaked
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: November 2014
Last updated: March 30, 2015
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