A Study of Two Different Formulations of LY3209590 in Healthy Participants

Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3209590

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3209590 Lyophilized Formulation; LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods.	Drug: LY3209590; Administered SC.
Experimental: LY3209590 Solution Formulation; LY3209590 as solution formulation administered SC in one of the two study periods.	Drug: LY3209590; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590	PK: Cmax of LY3209590	Predose on Day 1 through Day 65
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590	PK: AUC(0-inf) of LY3209590	Predose on Day 1 through Day 65

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 15, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 16494; I8H-MC-BDCJ (Other Identifier: Eli Lilly and Company); 2020-003738-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No