NCT06052462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

September 18, 2023

Last Update Submit

January 4, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • 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 Total Radioactivity in Plasma and Blood

    Predose up to Day 21 post dose

  • 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 Total Radioactivity in Plasma and Blood

    Predose up to Day 21 post dose

  • PK: Maximum Concentration (Cmax) of LY3556050 in Plasma

    Predose up to Day 21 post dose

  • +3 more secondary outcomes

Study Arms (1)

[14C]-LY3556050

EXPERIMENTAL

Single dose of \[¹⁴C\]-LY3556050 administered orally

Drug: [14C]-LY3556050

Interventions

[14C]-LY3556050DRUG

Administered orally

[14C]-LY3556050

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LabCorp CRU, Inc.

Madison, Wisconsin, 53704, United States

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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

September 20, 2023

Primary Completion

November 4, 2023

Study Completion

November 4, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)