Clinical trial NCT04049123: A Study of LY900014 in Healthy Chinese Participants
Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy native Chinese males or females
* Female participants:

  * Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study.
  * Women not of child-bearing potential who are infertile or post-menopausal
* Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
* Are nonsmokers
* Have a fasting plasma glucose value \>71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]) and \<108 mg/dL (6.0 mmol/L)

Exclusion Criteria:

* Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product
* Have previously completed or withdrawn from this study or any other study investigating LY900014
* Have known allergies to LY900014 or any components of the formulation
* Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study.
* Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days.
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Primary outcomes:
measure: Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
timeFrame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose
Secondary outcomes:
measure: Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
timeFrame: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose
Other outcomes:
Locations:
city: Cheng Du
country: China
facility: West China Hospital Sichuan University
state: Cn-51
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: