Healthy Clinical Trial
Official title:
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects
Verified date | October 15, 2019 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this trial is to evaluate the safety and tolerability of the study drug known as
LY3374849, when given as an injection to healthy participants.
The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and
how it affects the levels of blood sugar in comparison to insulin degludec, after a single
dose is given by injection under the skin and directly into a vein.
Participation in this study includes screening, which is required within 28 days before start
of study and a follow up at least 28 days after receiving the last dose of study drug.
This study has 3 parts:
- Participants in Part A will complete 1 study period (approximately 1 week).
- Participants in Part B will complete 3 study periods (approximately 3 weeks).
- Participants in Part C will complete 2 study periods (approximately 2 weeks).
Status | Completed |
Enrollment | 89 |
Est. completion date | September 27, 2019 |
Est. primary completion date | September 27, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Healthy male or a female who cannot become pregnant - Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²) - Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study - Have veins suitable for easy blood collection and glucose solution infusion Exclusion Criteria: - Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study - Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months - Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female) - Smoke more than 10 cigarettes per day - Are infected with hepatitis B or human immunodeficiency virus (HIV) - Have a history of allergies or reactions to more than one drug, or significant severe drug allergy - Are taking illegal drugs |
Country | Name | City | State |
---|---|---|---|
Singapore | Lilly Centre for Clinical Pharmacology | Singapore |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to study completion (estimated at 11 weeks) | |
Secondary | Glucodynamics: Total Amount of Glucose Infused (Gtot) | Glucodynamics: Gtot | Baseline up to 36 hours post-dose for each study arm | |
Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849 | Pharmacokinetics: AUC of LY3374849 | Baseline at predose through 6 days post-dose for each study arm |
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