A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants

Healthy Clinical Trial

Official title:

Disposition of [14C]-LY3556050 Following Oral Administration in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06052462
• Other study ID #: 18347
• Secondary ID: J2P-MC-LXBC
• Status: Completed
• Phase: Phase 1
• Start date: September 20, 2023
• Est. completion date: November 4, 2023

Study information

• Verified date: January 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 evaluate how much of the study drug (LY3556050), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 4, 2023
• Est. primary completion date: November 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male participants who are overtly healthy as determined by medical evaluation

• Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive

• Males who agree to use highly effective or effective methods of contraception

Exclusion Criteria:

• Have known allergies to LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy

• Have clinically significant abnormal BP and/or pulse rate as determined by the investigator

• Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-LY3556050
Administered orally

Locations

Country	Name	City	State
United States	LabCorp CRU, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 21 post dose
Primary	Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 21 post dose
Secondary	Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma	PK: AUC(0-tlast) of LY3556050 in Plasma	Predose up to Day 21 post dose
Secondary	PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood	PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood	Predose up to Day 21 post dose
Secondary	PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-8]) of LY3556050 in Plasma	PK: AUC (0-8) of LY3556050 in Plasma	Predose up to Day 21 post dose
Secondary	PK: AUC (0-8) of Total Radioactivity in Plasma and Blood	PK: AUC (0-8) of Total Radioactivity in Plasma and Blood	Predose up to Day 21 post dose
Secondary	PK: Maximum Concentration (Cmax) of LY3556050 in Plasma	PK: Cmax of LY3556050 in Plasma	Predose up to Day 21 post dose
Secondary	PK: Cmax of Total Radioactivity in Plasma and Blood	PK: Cmax of Total Radioactivity in Plasma and Blood	Predose up to Day 21 post dose
Secondary	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)	Predose up to Day 7 post dose
Secondary	Total Number of Metabolites of LY3556050	Total Number of Metabolites of LY3556050	Predose up to Day 7 post dose