Healthy
Conditions
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.
Interventions
DRUG[14C]-LY3556050
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed