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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06052462

Collaborator

(none)

Enrollment

Location

Arm

1.8

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: [14C]-LY3556050	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

Nov 13, 2023

Anticipated Study Completion Date :

Nov 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]-LY3556050 Single dose of [¹⁴C]-LY3556050 administered orally	Drug: [14C]-LY3556050 Administered orally

Arm

Intervention/Treatment

Experimental: [14C]-LY3556050

Single dose of [¹⁴C]-LY3556050 administered orally

Drug: [14C]-LY3556050

Administered orally

Outcome Measures

Primary Outcome Measures

Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to Day 21 post dose]
Urinary 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]
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma [Predose up to Day 21 post dose]
PK: AUC(0-tlast) of LY3556050 in Plasma
PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood [Predose up to Day 21 post dose]
PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood
PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma [Predose up to Day 21 post dose]
PK: AUC (0-∞) of LY3556050 in Plasma
PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood [Predose up to Day 21 post dose]
PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood
PK: Maximum Concentration (Cmax) of LY3556050 in Plasma [Predose up to Day 21 post dose]
PK: Cmax of LY3556050 in Plasma
PK: Cmax of Total Radioactivity in Plasma and Blood [Predose up to Day 21 post dose]
PK: Cmax of Total Radioactivity in Plasma and Blood
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) [Predose up to Day 7 post dose]
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Total Number of Metabolites of LY3556050 [Predose up to Day 7 post dose]
Total Number of Metabolites of LY3556050

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LabCorp CRU, Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT06052462

Other Study ID Numbers:

18347
J2P-MC-LXBC

First Posted:

Sep 25, 2023

Last Update Posted:

Sep 25, 2023

Last Verified:

Sep 15, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 25, 2023