A Study of Various Formulations of LY900014 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636361
• Other study ID #: 16176
• Secondary ID: I8B-FW-ITRJ
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY900014
Administered subcutaneously (SC)
• Insulin lispro (Humalog)
Administered SC

Locations

Country	Name	City	State
Singapore	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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.