A Relative Bioavailability Study of LY3209590 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3209590 (SC); Drug: LY3209590 (IV)

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3209590 (Part A - Upper Arm); LY3209590 administered subcutaneously (SC) into the upper arm	Drug: LY3209590 (SC); Administered SC.
Experimental: LY3209590 (Part A - Thigh); LY3209590 administered SC into the thigh	Drug: LY3209590 (SC); Administered SC.
Experimental: LY3209590 (Part A - Abdominal Wall); LY3209590 administered SC into the abdominal wall	Drug: LY3209590 (SC); Administered SC.
Experimental: LY3209590 (Part B - IV Dose); LY3209590 administered intravenously (IV)	Drug: LY3209590 (IV); Administered IV.
Experimental: LY3209590 (Part B - SC Dose); LY3209590 administered SC into the abdominal wall	Drug: LY3209590 (SC); Administered SC.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: PK: AUC0-∞ of LY3209590	Part B: PK: AUC0-∞ of LY3209590	Predose on Day 1 through Day 65

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Bioavailability; Injection sites
• Other Study ID Numbers: 18222; I8H-MC-BDDD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No