A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Male

Treatments: Drug: LY3549492; Drug: [14C]-LY3549492

Study type: Interventional

Funder types: Industry

Identifiers

NCT06194500

18348

J3H-MC-GZNC (Other Identifier)

U1111-1293-8652 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Carbon-14-Labeled [14C]-LY3549492 - Part A

Experimental group

Description:

Carbon-14-Labeled \[14C\]-LY3549492 administered as oral solution.

Treatment:

Drug: [14C]-LY3549492

Drug: [14C]-LY3549492

LY3549492 + [14C]-LY3549492 - Part B

Experimental group

Description:

LY3549492 administered as oral solution followed 3 hours later by \[14C\] LY3549492 will be administered as intravenous (IV) infusion.

Treatment:

Drug: [14C]-LY3549492

Drug: [14C]-LY3549492

Drug: LY3549492