Title
A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
A Single Site, Randomized, Four-Way, Four-Period PK/PD Crossover Phase 1 Clinical Study in 16 Fasted Healthy Adult Volunteers Receiving 3 Dose Levels of Intranasally Administered Glucagon and One Dose Level of Glucagon Administered by Subcutaneous Injection
Phase
Phase 1Lead Sponsor
Eli LillyStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
glucagon ...Study Participants
16The 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.
Administered intranasally.
Administered SC.
Ng dose at 0.5 milligram (mg) administered once in one of four study periods.
Ng dose at 1.0 milligram (mg) administered once in one of four study periods.
Ng dose at 2.0 milligram (mg) administered once in one of four study periods.
Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.
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.
| Event Type | Organ System | Event Term | NG 0.5 mg | NG 1 mg | NG 2 mg | SC Glucagon 1 mg |
|---|
Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
