Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Conditions:

Healthy Male

Eligibility:

MALE

35-65 years

Phase:

PHASE1

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...

Eligibility Criteria

Inclusion

  • 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

  • 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)).

Key Trial Info

Start Date :

January 3 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 15 2024

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT06194500

Start Date

January 3 2024

End Date

February 15 2024

Last Update

March 28 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Fortrea Clinical Research Unit

Holbeck, Leeds, United Kingdom, LS11 9EH