search
Back to results

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

Primary Purpose

Renal Insufficiency

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3473329
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Velocity Clinical ResearchRecruiting
  • Advanced Pharma CR, LLCRecruiting
  • Orlando Clinical Research CenterRecruiting
  • Alliance for Multispecialty Research - Clinical Research ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

LY3473329 (Control)

LY3473329 (Mild Renal Impairment)

LY3473329 (Moderate Renal Impairment)

LY3473329 (Severe Renal Impairment)

LY3473329 (End-Stage Renal Disease)

Arm Description

LY3473329 administered orally to participants with normal renal function

LY3473329 administered orally to participants with mild renal impairment

LY3473329 administered orally to participants with moderate renal impairment

LY3473329 administered orally to participants with severe renal impairment

LY3473329 administered orally to participants with end-stage renal disease

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
PK: AUC0-∞ of LY3473329
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329
PK: AUC0-tlast of LY3473329
PK: Maximum observed concentration (Cmax) of LY3473329
PK: Cmax of LY3473329

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
August 12, 2023
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT05778864
Brief Title
A Study of LY3473329 in Participants With Impaired and Normal Renal Function
Official Title
Pharmacokinetics of LY3473329 Following Oral Administration in Participants With Renal Impairment Compared With Participants With Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
December 4, 2023 (Anticipated)
Study Completion Date
December 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3473329 (Control)
Arm Type
Experimental
Arm Description
LY3473329 administered orally to participants with normal renal function
Arm Title
LY3473329 (Mild Renal Impairment)
Arm Type
Experimental
Arm Description
LY3473329 administered orally to participants with mild renal impairment
Arm Title
LY3473329 (Moderate Renal Impairment)
Arm Type
Experimental
Arm Description
LY3473329 administered orally to participants with moderate renal impairment
Arm Title
LY3473329 (Severe Renal Impairment)
Arm Type
Experimental
Arm Description
LY3473329 administered orally to participants with severe renal impairment
Arm Title
LY3473329 (End-Stage Renal Disease)
Arm Type
Experimental
Arm Description
LY3473329 administered orally to participants with end-stage renal disease
Intervention Type
Drug
Intervention Name(s)
LY3473329
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
Description
PK: AUC0-∞ of LY3473329
Time Frame
Predose up to 34 days postdose
Title
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329
Description
PK: AUC0-tlast of LY3473329
Time Frame
Predose up to 34 days postdose
Title
PK: Maximum observed concentration (Cmax) of LY3473329
Description
PK: Cmax of LY3473329
Time Frame
Predose up to 34 days postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Chang
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-220-2727
First Name & Middle Initial & Last Name & Degree
Kimberly Cruz
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-240-7878
First Name & Middle Initial & Last Name & Degree
Thomas Marbury
Facility Name
Alliance for Multispecialty Research - Clinical Research Consortium
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William B. Smith

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs