Clinical trial NCT02752087: A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
Official title: A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY900014 Test Versus Reference Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.


Eligibility criteria: Inclusion Criteria:

* Female participants who can potentially get pregnant:

  * Must have a negative pregnancy test at the time of screening
  * Agree to continue to use a reliable method of birth control until the end of the study
* Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive, at screening
* Are nonsmokers, have not smoked for at least 2 months before entering the study

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have known allergies to insulin lispro, related compounds, or any components of the formulation
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, before dosing (apart from vitamin/mineral supplements, occasional paracetamol, hormonal contraception, or thyroid-replacement therapy)
* Have used systemic glucocorticoids within 3 months prior to entry into the study
* Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or provided any blood donation within the last month before screening

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
timeFrame: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment
Secondary outcomes:
measure: Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
timeFrame: Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
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)
role: STUDY_DIRECTOR
References: