A Study to Compare 2 Formulations of LY900014 in Healthy Participants

Healthy Clinical Trial

Official title:

Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY900014 U-200 Formulation With LY900014 U-100 Formulation in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334448
• Other study ID #: 16636
• Secondary ID: I8B-MC-ITRQ
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)

• Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)

• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

• Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

• Have previously participated or withdrawn from this study

• Had blood loss of more than 450 milliliters (mL) within the last 3 months

• Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)

• Smoke more than 10 cigarettes per day

• Are infected with hepatitis B or human immunodeficiency virus (HIV)

• Are taking illegal drugs

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY900014-U200
Administered SC
• LY900014-U100
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): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])	Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC[0-10h])	Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)
Secondary	Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm	Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp (EC) procedure.	Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose