A Study of Various Formulations of LY900014 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY900014; Drug: Insulin lispro (Humalog)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636361

16176

I8B-FW-ITRJ (Other Identifier)

Details and patient eligibility

About

This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

Enrollment: 26 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
• Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
• Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
• Have veins suitable for easy blood collection and glucose solution infusion

Exclusion criteria

• Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
• Show signs of having an infection or infectious disease at the time of study entry

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 5 patient groups

LY900014 Test B

Experimental group

Description:

Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods

Treatment:

Drug: LY900014

LY900014 Test A

Experimental group

Description:

Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods

Treatment:

Drug: LY900014

LY900014 Test C

Experimental group

Description:

Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods

Treatment:

Drug: LY900014

LY900014 Test D

Experimental group

Description:

Formulation D: Single dose of LY900014 formulation administered SC in one of five periods

Treatment:

Drug: LY900014

Insulin Lispro

Active Comparator group

Description:

Reference formulation: Single dose of lispro administered SC in one of five periods

Treatment:

Drug: Insulin lispro (Humalog)