A Study of LY900014 Formulations in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: LY900014 Test A

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

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

Part A:Insulin Lispro

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

Group Type EXPERIMENTAL

Insulin Lispro

Intervention Type BIOLOGICAL

Administered SC

Part A: LY900014 Test B

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

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

Part A: LY900014 Test C

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

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

Part A: LY900014 Test D

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

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

Part B: LY900014

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

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

Interventions

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LY900014

Administered SC

Intervention Type BIOLOGICAL

Insulin Lispro

Administered SC

Intervention Type BIOLOGICAL

Other Intervention Names

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Ultra-Rapid Lispro LY275585

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes