A Study of LY3473329 in Participants With Impaired and Normal Renal Function

Renal Insufficiency Clinical Trial

Official title:

Pharmacokinetics of LY3473329 Following Oral Administration in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778864
• Other study ID #: 18638
• Secondary ID: J2O-MC-EKBE
• Status: Recruiting
• Phase: Phase 1
• Start date: March 17, 2023
• Est. completion date: October 10, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 10, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)

• Men who agree to use highly effective or effective methods of contraception, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial

• Have clinical laboratory test results within the normal reference range for the population

Exclusion Criteria:

• Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study

• Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study

• Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms

• Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age

• Smoke more than 10 cigarettes per day or the equivalent

• Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• LY3473329
Administered orally.

Locations

Country	Name	City	State
United States	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-8) of LY3473329	PK: AUC0-8 of LY3473329	Predose up to 34 days postdose
Primary	PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329	PK: AUC0-tlast of LY3473329	Predose up to 34 days postdose
Primary	PK: Maximum observed concentration (Cmax) of LY3473329	PK: Cmax of LY3473329	Predose up to 34 days postdose