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

NCT06194500 | Completed Phase 1

• 3 other identifiers: 18348J3H-MC-GZNCU1111-1293-8652
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (9)

• 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: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A

  Predose up to Day 24 postdose in Part A

• PK: AUC of LY3549492 in Plasma in Part A

  Predose up to Day 24 postdose in Part A

• PK: Cmax of LY3549492 in Plasma 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

  Predose up to Day 24 postdose in Part A

Study Arms (2)

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

EXPERIMENTAL

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

Drug: [14C]-LY3549492

LY3549492 + [14C]-LY3549492 - Part B

EXPERIMENTAL

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

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

Interventions

[14C]-LY3549492 DRUG

Administered as oral solution.

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

LY3549492 DRUG

Administered orally.

LY3549492 + [14C]-LY3549492 - Part B

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Holbeck, Leeds, LS11 9EH, United Kingdom

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 8, 2024
• Study Start: January 3, 2024
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)