A Study of LY900014 Formulations in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: LY900014; Biological: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT02317575

I8B-FW-ITRA (Other Identifier)

15645

Details and patient eligibility

About

This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.

Enrollment: 29 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)
• Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
• Are nonsmokers, 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

Exclusion criteria

• Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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29 participants in 6 patient groups

Part A: LY900014 Test A

Experimental group

Description:

Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.

Treatment:

Biological: LY900014

Part A:Insulin Lispro

Experimental group

Description:

Reference formulation. 15 U insulin lispro administered SC in one of five periods.

Treatment:

Biological: Insulin Lispro

Part A: LY900014 Test B

Experimental group

Description:

Test Formulation B. Single dose LY900014 administered subcutaneously (SC) in one of five periods.

Treatment:

Biological: LY900014

Part A: LY900014 Test C

Experimental group

Description:

Test Formulation C. Single dose LY900014administered subcutaneously (SC) in one of five periods.

Treatment:

Biological: LY900014

Part A: LY900014 Test D

Experimental group

Description:

Test Formulation D. Single dose LY900014administered subcutaneously (SC) in one of five periods.

Treatment:

Biological: LY900014

Part B: LY900014

Experimental group

Description:

Test formulation selected from Part A. Single dose of LY900014 administered SC in one of four periods.

Treatment:

Biological: LY900014