Study to Compare 2 Formulations of LY900014 in Healthy Participants

Healthy Clinical Trial

Official title:

Bioequivalence Study Comparing 2 Formulations of LY900014 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616977
• Other study ID #: 17152
• Secondary ID: I8B-MC-ITSS
• Status: Completed
• Phase: Phase 1
• Start date: August 3, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: November 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 2 formulations of LY900014, which 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: 69
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 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

• Had donated blood of more than 450 milliliters (mL) or participated in a clinical trial with similar blood loss 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 U-200
Administered SC
• LY900014 U-100
Administered SC

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	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: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm	Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.	Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose
Secondary	Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm	GD: 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 procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate.	Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose