A Relative Bioavailability Study of LY3209590 in Healthy Participants

NCT05615532 | Completed Phase 1

• 2 other identifiers: 18222I8H-MC-BDDD
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability; Injection sites

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Part B: PK: AUC0-∞ of LY3209590

  Predose on Day 1 through Day 65

Study Arms (5)

LY3209590 (Part A - Upper Arm)

EXPERIMENTAL

LY3209590 administered subcutaneously (SC) into the upper arm

Drug: LY3209590 (SC)

LY3209590 (Part A - Thigh)

EXPERIMENTAL

LY3209590 administered SC into the thigh

Drug: LY3209590 (SC)

LY3209590 (Part A - Abdominal Wall)

EXPERIMENTAL

LY3209590 administered SC into the abdominal wall

Drug: LY3209590 (SC)

LY3209590 (Part B - IV Dose)

EXPERIMENTAL

LY3209590 administered intravenously (IV)

Drug: LY3209590 (IV)

LY3209590 (Part B - SC Dose)

EXPERIMENTAL

LY3209590 administered SC into the abdominal wall

Drug: LY3209590 (SC)

Interventions

LY3209590 (SC) DRUG

Administered SC.

LY3209590 (Part A - Abdominal Wall); LY3209590 (Part A - Thigh); LY3209590 (Part A - Upper Arm); LY3209590 (Part B - SC Dose)

LY3209590 (IV) DRUG

Administered IV.

LY3209590 (Part B - IV Dose)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A is Parallel design and Part B is a crossover design

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 14, 2022
• Study Start: November 11, 2022
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)