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Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons

NCT02403648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BIOD-961

BIOD-961 is a lyophilized glucagon formulation.

DRUG

Lilly Glucagon

DRUG

Novo Glucagon

Sponsors & Collaborators

  • Biodel

    lead INDUSTRY

Principal Investigators

  • Linda Morrow, MD · Profil Institute for Clinical Research, Inc.

  • Alan Krasner, MD · Biodel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02403648 on ClinicalTrials.gov