Clinical trial NCT05778864: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-03-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
timeFrame: Predose up to 34 days postdose
measure: PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329
timeFrame: Predose up to 34 days postdose
measure: PK: Maximum observed concentration (Cmax) of LY3473329
timeFrame: Predose up to 34 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Edgewater
country: United States
facility: Velocity Clinical Research, New Smyrna Beach
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: