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Completed

NCT Number: NCT04768842

A Study of Two Different Formulations of LY3209590 in Healthy Participants

The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
  • Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
  • Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
  • Have veins suitable for blood sampling
  • Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion criteria

  • Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Are women who are pregnant or lactating
  • Have a history of multiple and/or severe allergic reactions
  • Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
  • Regularly use known drugs of abuse or with positive drug results

Treatment and study plan

LY3209590

Drug

Administered SC.

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590

    Time frame: Predose on Day 1 through Day 65

    PK: Cmax of LY3209590

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590

    Time frame: Predose on Day 1 through Day 65

    PK: AUC(0-inf) of LY3209590

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2021
Registry last updated
Sep 27, 2021

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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