NCT02403648

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Biodel · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	BIOD-961	BIOD-961 is a lyophilized glucagon formulation.
DRUG	Lilly Glucagon
DRUG	Novo Glucagon

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-03-01
• First posted: 2015-03-31
• Last updated: 2016-01-15