A Study of Two Different Formulations of LY3209590 in Healthy Participants

NCT04768842 | Completed Phase 1 FDA Drug

• 3 other identifiers: 16494I8H-MC-BDCJ2020-003738-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

LY3209590 Lyophilized Formulation

EXPERIMENTAL

LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods.

Drug: LY3209590

LY3209590 Solution Formulation

EXPERIMENTAL

LY3209590 as solution formulation administered SC in one of the two study periods.

Drug: LY3209590

Interventions

LY3209590 DRUG

Administered SC.

LY3209590 Lyophilized Formulation; LY3209590 Solution Formulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research

Leeds, LS2 9LH, United Kingdom

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 24, 2021
• Study Start: March 3, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09-15

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)