A Study of Two Different Formulations of LY3209590 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768842
• Other study ID #: 16494
• Secondary ID: I8H-MC-BDCJ2020-
• Status: Completed
• Phase: Phase 1
• Start date: March 3, 2021
• Est. completion date: September 3, 2021

Study information

• Verified date: September 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3209590
Administered SC.

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590	PK: Cmax of LY3209590	Predose on Day 1 through Day 65
Primary	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