A Study of Two Different Formulations of LY3209590 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3209590

• Registration Number: NCT04768842
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-24
• Study Start: 2021-03-03
• Primary Completion: 2021-09-03
• Study Completion: 2021-09-03
• Status Verified: 2021-09-15
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3209590 Lyophilized Formulation	LY3209590	LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods.
LY3209590 Solution Formulation	LY3209590	LY3209590 as solution formulation administered SC in one of the two study periods.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research; 🇬🇧 Leeds, United Kingdom