Status:
COMPLETED
A Study of LY900014 in Healthy Chinese Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- 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
- 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- Have previously completed or withdrawn from this study or any other study investigating LY900014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)
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04049123
Start Date
November 18 2019
End Date
October 23 2020
Last Update
November 16 2021
Active Locations (1)
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1
West China Hospital Sichuan University
Chengdu, Cn-51, China, 610041