A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Glucagon; Drug: Nasal Glucagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT02778113

I8R-MC-IGBD (Other Identifier)

16424

AMG 101 (Other Identifier)

GUO-P1-557 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. The study lasted about 23 days for each participant.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m².
• Light-, non- or ex-smokers.
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis).

Exclusion criteria

• Presence of any nose piercings.
• History of significant hypersensitivity to glucagon or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
• Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy.
• Fasting blood glucose above 5.0 millimoles per liter (mmol/L) at screening, following a 12-hour fasting period.
• Fasting blood glucose assessed with a glucose meter above 5.5 mmol/L 0.5 hour before each dosing.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 4 patient groups

Nasal Glucagon (NG) - 0.5 mg

Experimental group

Description:

Ng dose at 0.5 milligram (mg) administered once in one of four study periods.

Treatment:

Drug: Nasal Glucagon

NG - 1.0 mg

Experimental group

Description:

Ng dose at 1.0 milligram (mg) administered once in one of four study periods.

Treatment:

Drug: Nasal Glucagon

NG - 2.0 mg

Experimental group

Description:

Ng dose at 2.0 milligram (mg) administered once in one of four study periods.

Treatment:

Drug: Nasal Glucagon

SC Glucagon 1 mg

Active Comparator group

Description:

Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.

Treatment:

Drug: Glucagon