A Relative Bioavailability Study of LY3209590 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3209590 (SC); Drug: LY3209590 (IV)

• Registration Number: NCT05615532
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Study Start: 2022-11-11
• Study First Posted: 2022-11-14
• Primary Completion: 2023-06-28
• Study Completion: 2023-06-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3209590 (Part A - Upper Arm)	LY3209590 (SC)	LY3209590 administered subcutaneously (SC) into the upper arm
LY3209590 (Part A - Thigh)	LY3209590 (SC)	LY3209590 administered SC into the thigh
LY3209590 (Part A - Abdominal Wall)	LY3209590 (SC)	LY3209590 administered SC into the abdominal wall
LY3209590 (Part B - IV Dose)	LY3209590 (IV)	LY3209590 administered intravenously (IV)
LY3209590 (Part B - SC Dose)	LY3209590 (SC)	LY3209590 administered SC into the abdominal wall

Primary Outcome Measures

Name	Time	Method
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590	Predose on Day 1 through Day 65	Part A: PK: AUC0-∞ of LY3209590

Secondary Outcome Measures

Name	Time	Method
Part B: PK: AUC0-∞ of LY3209590	Predose on Day 1 through Day 65	Part B: PK: AUC0-∞ of LY3209590

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore