Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02752087 |
Date of registration:
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22/04/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants
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Scientific title:
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A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY900014 Test Versus Reference Formulations in Healthy Subjects |
Date of first enrolment:
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April 2016 |
Target sample size:
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24 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02752087 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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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) |
Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: LY900014
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Primary Outcome(s)
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Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
[Time Frame: 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]
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Secondary Outcome(s)
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Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
[Time Frame: 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]
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Secondary ID(s)
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I8B-MC-ITRP
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16489
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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