A Study of a New LY900014 Formulation in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02525744
• Date of registration: 14/08/2015
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of a New LY900014 Formulation in Healthy Participants
• Scientific title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation
• Date of first enrolment: August 2015
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02525744
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• 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:

- Overtly healthy male or a female (not pregnant and agreeable to take birth control
measures until one month after study completion)

- Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2),
inclusive, at screening

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

- Are nonsmokers, 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

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- Have previously participated or withdrawn from this study

- Have or used to have health problems or laboratory test results or ECG readings that,
in the opinion of the doctor, could make it unsafe to participate, or could interfere
with understanding the results of the study



Age minimum: 21 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Insulin Lispro (Humalog)

Drug: LY900014

Primary Outcome(s)

Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-8]) ) [Time Frame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.]

Secondary Outcome(s)

Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp [Time Frame: Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes]

Secondary ID(s)

15989

I8B-FW-ITRE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02525744