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Completed

NCT Number: NCT06194500

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

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.

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Key information

Conditions

Healthy Male

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Holbeck, Leeds, LS11 9EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)).

Treatment and study plan

[14C]-LY3549492

Drug

Administered as oral solution.

LY3549492

Drug

Administered orally.

Primary outcomes

  1. Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A

    Time frame: 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

  2. Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total

  3. Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B

    Time frame: Predose up to Day 7 postdose in Part B

    PK: AUC for oral determination of absolute bioavailability (F) of LY3549492

  4. PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B

    Time frame: Predose up to Day 7 postdose in Part B

    PK: AUC for IV determination of absolute bioavailability (F) of LY3549492

Secondary outcomes

  1. PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    PK: AUC for radioactivity

  2. PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    PK: Cmax for radioactivity

  3. PK: AUC of LY3549492 in Plasma in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    PK: AUC of LY3549492 in plasma

  4. PK: Cmax of LY3549492 in Plasma in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    PK: Cmax of LY3549492 in plasma

  5. Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    Total radioactivity recovered in urine, feces, and expired air (if applicable) in Part A

  6. Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A

    Time frame: Predose up to Day 24 postdose in Part A

    Total number of metabolites and identification of metabolites of LY3549492

  7. PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B

    Time frame: Predose up to Day 7 postdose in Part B

    AUC of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B

  8. PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B

    Time frame: Predose up to Day 7 postdose in Part B

    Cmax of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B

  9. Total Radioactivity Recovered in Urine and Feces in Part B

    Time frame: Predose up to Day 7 postdose in Part B

    Total radioactivity recovered in urine and feces in Part B

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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