ClinicalTrials.Veeva

Menu

A Study of Various Formulations of LY900014 in Healthy Participants

Lilly logo

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

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems