Clinical trial NCT06052462: A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants
Official title: Disposition of [14C]-LY3556050 Following Oral Administration in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 21 post dose
measure: Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 21 post dose
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma
timeFrame: Predose up to Day 21 post dose
measure: PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood
timeFrame: Predose up to Day 21 post dose
measure: PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma
timeFrame: Predose up to Day 21 post dose
measure: PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood
timeFrame: Predose up to Day 21 post dose
measure: PK: Maximum Concentration (Cmax) of LY3556050 in Plasma
timeFrame: Predose up to Day 21 post dose
measure: PK: Cmax of Total Radioactivity in Plasma and Blood
timeFrame: Predose up to Day 21 post dose
measure: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
timeFrame: Predose up to Day 7 post dose
measure: Total Number of Metabolites of LY3556050
timeFrame: Predose up to Day 7 post dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: LabCorp CRU, Inc.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: