A Study of LY3374849 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726125
• Other study ID #: 16939
• Secondary ID: I9R-MC-BSDA
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2018
• Est. completion date: September 27, 2019

Study information

• Verified date: October 15, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Parts B and C added per protocol amendment, approved in April 2019.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3374849 - SC
Administered SC
• Insulin Degludec - SC
Administered SC
• LY3374849 - IV
Administered IV
• Insulin Degludec - IV
Administered IV

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

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