A Relative Bioavailability Study of LY3209590 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3209590 (IV); Drug: LY3209590 (SC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05615532

I8H-MC-BDDD (Other Identifier)

18222

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

168 participants in 5 patient groups

LY3209590 (Part A - Upper Arm)

Experimental group

Description:

LY3209590 administered subcutaneously (SC) into the upper arm

Treatment:

Drug: LY3209590 (SC)

LY3209590 (Part A - Thigh)

Experimental group

Description:

LY3209590 administered SC into the thigh

Treatment:

Drug: LY3209590 (SC)

LY3209590 (Part A - Abdominal Wall)

Experimental group

Description:

LY3209590 administered SC into the abdominal wall

Treatment:

Drug: LY3209590 (SC)

LY3209590 (Part B - IV Dose)

Experimental group

Description:

LY3209590 administered intravenously (IV)

Treatment:

Drug: LY3209590 (IV)

LY3209590 (Part B - SC Dose)

Experimental group

Description:

LY3209590 administered SC into the abdominal wall

Treatment:

Drug: LY3209590 (SC)