A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants
- Registration Number
- NCT06194500
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
- 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.
- 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)).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3549492 + [14C]-LY3549492 - Part B [14C]-LY3549492 LY3549492 administered as oral solution followed 3 hours later by \[14C\] LY3549492 will be administered as intravenous (IV) infusion. Carbon-14-Labeled [14C]-LY3549492 - Part A [14C]-LY3549492 Carbon-14-Labeled \[14C\]-LY3549492 administered as oral solution. LY3549492 + [14C]-LY3549492 - Part B LY3549492 LY3549492 administered as oral solution followed 3 hours later by \[14C\] LY3549492 will be administered as intravenous (IV) infusion.
- Primary Outcome Measures
Name Time Method Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A Predose up to Day 24 postdose in Part A Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose
PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B Predose up to Day 7 postdose in Part B PK: AUC for IV determination of absolute bioavailability (F) of LY3549492
Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A Predose up to Day 24 postdose in Part A Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total
Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B Predose up to Day 7 postdose in Part B PK: AUC for oral determination of absolute bioavailability (F) of LY3549492
- Secondary Outcome Measures
Name Time Method PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A Predose up to Day 24 postdose in Part A PK: AUC for radioactivity
PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A Predose up to Day 24 postdose in Part A PK: Cmax for radioactivity
PK: AUC of LY3549492 in Plasma in Part A Predose up to Day 24 postdose in Part A PK: AUC of LY3549492 in plasma
PK: Cmax of LY3549492 in Plasma in Part A Predose up to Day 24 postdose in Part A PK: Cmax of LY3549492 in plasma
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A Predose up to Day 24 postdose in Part A Total radioactivity recovered in urine, feces, and expired air (if applicable) in Part A
Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A Predose up to Day 24 postdose in Part A Total number of metabolites and identification of metabolites of LY3549492
PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B Predose up to Day 7 postdose in Part B AUC of LY3549492, \[14C\]-LY3549492, and total radioactivity in plasma in Part B
PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B Predose up to Day 7 postdose in Part B Cmax of LY3549492, \[14C\]-LY3549492, and total radioactivity in plasma in Part B
Total Radioactivity Recovered in Urine and Feces in Part B Predose up to Day 7 postdose in Part B Total radioactivity recovered in urine and feces in Part B
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit
🇬🇧Holbeck, Leeds, United Kingdom