A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

Healthy Clinical Trial

Official title:

A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003465
• Other study ID #: 18530
• Secondary ID: J1I-MC-GZBX
• Status: Completed
• Phase: Phase 1
• Start date: August 29, 2023
• Est. completion date: February 8, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 8, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures

• Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive

• Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study

• Are agreeable to receiving study treatment by injections under the skin

• Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)

Exclusion Criteria:

• Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

• Smoke more than the equivalent of 10 cigarettes per day

• Is a known user of drugs of abuse

• Have known allergies to LY3437943 or related compounds

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3437943
Administered SC

Device:
• Test
Used to administer LY3437943 SC
• Reference
Used to administer LY3437943 SC

Locations

Country	Name	City	State
United States	Qps-Mra, Llc	Miami	Florida
United States	ICON	Salt Lake City	Utah
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943	PK: Cmax of LY3437943	Predose up to 43 days postdose
Primary	PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943	PK: AUC[0-tlast] of LY3437943	Predose up to 43 days postdose
Primary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3437943	PK: AUC(0-8) of LY3437943	Predose up to 43 days postdose