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OpenTrials
Completed

NCT Number: NCT04049123

A Study of LY900014 in Healthy Chinese Participants

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital Sichuan University

Chengdu, Cn-51, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating LY900014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)

Treatment and study plan

LY900014

Drug

Administered SC

Other names: Ultra-Rapid Lispro

Insulin Lispro

Drug

Administered SC

Other names: LY275585, Humalog

Primary outcomes

  1. Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])

    Time frame: 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

    PK: Insulin Lispro AUC(0-10h)

Secondary outcomes

  1. Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)

    Time frame: 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

    Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2019
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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