A Study to Compare 2 Formulations of LY900014 in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03334448
• Date of registration: 03/11/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study to Compare 2 Formulations of LY900014 in Healthy Participants
• Scientific title: Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY900014 U-200 Formulation With LY900014 U-100 Formulation in Healthy Subjects
• Date of first enrolment: December 4, 2017
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03334448
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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- Have previously participated or withdrawn from this study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



Age minimum: 21 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: LY900014-U200

Drug: LY900014-U100

Primary Outcome(s)

Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10]) [Time Frame: 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 Outcome(s)

Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm [Time Frame: Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose]

Secondary ID(s)

16636

I8B-MC-ITRQ

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03334448