A Study of Various Formulations of LY900014 in Healthy Participants

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Multiple LY900014 Formulations

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY900014; Drug: Insulin lispro (Humalog)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY900014 Test B; Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
EXPERIMENTAL: LY900014 Test A; Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
EXPERIMENTAL: LY900014 Test C; Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
EXPERIMENTAL: LY900014 Test D; Formulation D: Single dose of LY900014 formulation administered SC in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
ACTIVE_COMPARATOR: Insulin Lispro; Reference formulation: Single dose of lispro administered SC in one of five periods	Drug: Insulin lispro (Humalog); Administered SC; Other Names: Humalog; LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro	Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp	Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (ESTIMATE): December 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 16176; I8B-FW-ITRJ (OTHER: Eli Lilly and Company)