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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05615532

Enrollment

168

Registered

2022-11-14

Start date

2022-11-11

Completion date

2023-06-28

Last updated

2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioavailability, Injection sites

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.

Interventions

DRUGLY3209590 (SC)

Administered SC.

DRUGLY3209590 (IV)

Administered IV.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Part A is Parallel design and Part B is a crossover design

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026