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OpenTrials
Completed

NCT Number: NCT05615532

A Relative Bioavailability Study 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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3209590 (SC)

Drug

Administered SC.

LY3209590 (IV)

Drug

Administered IV.

Primary outcomes

  1. Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590

    Time frame: Predose on Day 1 through Day 65

    Part A: PK: AUC0-∞ of LY3209590

Secondary outcomes

  1. Part B: PK: AUC0-∞ of LY3209590

    Time frame: Predose on Day 1 through Day 65

    Part B: PK: AUC0-∞ of LY3209590

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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