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

Healthy Male Clinical Trial

Official title:

An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [14C]-LY3549492 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06194500
• Other study ID #: 18348
• Secondary ID: J3H-MC-GZNCU1111
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2024
• Est. completion date: February 15, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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)).

Related Conditions & MeSH terms

• Healthy Male

Intervention

Drug:
• [14C]-LY3549492
Administered as oral solution.
• LY3549492
Administered orally.
• [14C]-LY3549492
Administered as IV infusion.

Locations

Country	Name	City	State
United Kingdom	Fortrea Clinical Research Unit	Holbeck	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A	Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose	Predose up to Day 24 postdose in Part A
Primary	Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A	Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total	Predose up to Day 24 postdose in Part A
Primary	Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B	PK: AUC for oral determination of absolute bioavailability (F) of LY3549492	Predose up to Day 7 postdose in Part B
Primary	PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B	PK: AUC for IV determination of absolute bioavailability (F) of LY3549492	Predose up to Day 7 postdose in Part B
Secondary	PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A	PK: AUC for radioactivity	Predose up to Day 24 postdose in Part A
Secondary	PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A	PK: Cmax for radioactivity	Predose up to Day 24 postdose in Part A
Secondary	PK: AUC of LY3549492 in Plasma in Part A	PK: AUC of LY3549492 in plasma	Predose up to Day 24 postdose in Part A
Secondary	PK: Cmax of LY3549492 in Plasma in Part A	PK: Cmax of LY3549492 in plasma	Predose up to Day 24 postdose in Part A
Secondary	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A	Total radioactivity recovered in urine, feces, and expired air (if applicable) in Part A	Predose up to Day 24 postdose in Part A
Secondary	Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A	Total number of metabolites and identification of metabolites of LY3549492	Predose up to Day 24 postdose in Part A
Secondary	PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B	AUC of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B	Predose up to Day 7 postdose in Part B
Secondary	PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B	Cmax of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B	Predose up to Day 7 postdose in Part B
Secondary	Total Radioactivity Recovered in Urine and Feces in Part B	Total radioactivity recovered in urine and feces in Part B	Predose up to Day 7 postdose in Part B