A Relative Bioavailability Study of LY3209590 in Healthy Participants

Healthy Clinical Trial

Official title:

Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615532
• Other study ID #: 18222
• Secondary ID: I8H-MC-BDDD
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2022
• Est. completion date: June 28, 2023

Study information

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

Clinical Trial Summary

The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.

The study may last up to 65 (part A) and 184 (part B) days, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female participants who are overtly healthy as determined by medical evaluation

• Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)

• Male or female participants must agree to use contraception

Exclusion Criteria:

• Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction

• Have known allergies to LY3209590, related compounds, or any components of the formulation

• Have an abnormality in the 12-lead electrocardiogram

• Intend to use prescription medication, including herbal medications and traditional medications

• Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen

• Are lactating or pregnant

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3209590 (SC)
Administered SC.
• LY3209590 (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	Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3209590	Part A: PK: AUC0-8 of LY3209590	Predose on Day 1 through Day 65
Secondary	Part B: PK: AUC0-8 of LY3209590	Part B: PK: AUC0-8 of LY3209590	Predose on Day 1 through Day 65