Healthy Male
Conditions
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.
Interventions
DRUG[14C]-LY3549492
Administered as oral solution.
DRUGLY3549492
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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)).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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 |
| 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: 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 |
Countries
United Kingdom
Outcome results
None listed