Clinical trial NCT06194500: A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants
Official title: An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [14C]-LY3549492 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 18
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
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 measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will be conducted in healthy males and has two parts. In Part A, participants will receive carbon-14 (14C) radiolabeled LY3549492 (\[14C\] LY3549492) given by mouth. In Part B, participants will receive LY3549492 by mouth. Three hours later, participants will receive \[14C\] LY3549492 given into a vein.

The radioactive substance C14 will be incorporated into the study drug to investigate the study drug and breakdown products to find out how much of these passes from blood into urine, stool, and breath.

The study will last about 2 months in Part A and about 1½ months in Part B. This includes screening, treatment, and follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
* Participants who have safety laboratory test results within normal reference ranges, or results with acceptable deviations that are deemed not clinically significant by the investigator.
* Body mass index (BMI) within the range of 20.0 to 40.0 kilograms per meter squared (kg/m2), inclusive.
* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Have known allergies to LY3549492, glucagon-like peptide-1 (GLP-1) non-peptide agonist (NPA)-related compounds or any components of the formulation as appropriate, or history of atopy.
* Have a clinical diagnosis of a long QT syndrome.
* Have any abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participation in the study or may confound ECG data analysis.
* Have significant history of any current serious medical condition.
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or have an elevation in serum amylase or lipase (\>1.0×Upper Limit Normal (ULN)).

Primary outcomes:
measure: Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B
timeFrame: Predose up to Day 7 postdose in Part B
measure: PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B
timeFrame: Predose up to Day 7 postdose in Part B
Secondary outcomes:
measure: PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: PK: AUC of LY3549492 in Plasma in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: PK: Cmax of LY3549492 in Plasma in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A
timeFrame: Predose up to Day 24 postdose in Part A
measure: PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B
timeFrame: Predose up to Day 7 postdose in Part B
measure: PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B
timeFrame: Predose up to Day 7 postdose in Part B
measure: Total Radioactivity Recovered in Urine and Feces in Part B
timeFrame: Predose up to Day 7 postdose in Part B
Other outcomes:
Locations:
city: Holbeck
country: United Kingdom
facility: Fortrea Clinical Research Unit
state: Leeds
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: