A Study of Various Formulations of LY900014 in Healthy Participants

May 12, 2020 updated by: Eli Lilly and Company

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
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
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 16176
  • I8B-FW-ITRJ (OTHER: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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