Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate how much of the study drug (LY3871801), 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 9 weeks including the screening period.
Interventions
DRUG[14C]-LY3871801
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
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male participants who are overtly healthy as determined by medical evaluation * Have a body mass index of 18.5 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 LY3871801, related compounds, or any components of the formulation, or a history of significant atopy * Have received or intend to receive any vaccination within 30 days prior to dosing until the follow-up phone call * Have participated in a radiolabeled drug study, where exposures are known to the investigator or designee, within 4 months prior to check-in, or participated in a radiolabeled drug study, where exposures are not known to the investigator or designee, within 6 months prior to check-in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 7 post dose | Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
| Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 7 post dose | Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801 | Predose up to Day 7 post dose | PK: Cmax of \[¹⁴C\]-LY3871801 |
| PK: Cmax of Total Radioactivity | Predose up to Day 7 post dose | PK: Cmax of Total Radioactivity |
| Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-∞]) of [¹⁴C]-LY3871801 | Predose up to Day 7 post dose | PK: AUC \[0-∞\] of \[¹⁴C\]-LY3871801 |
| Total Number of Metabolites of LY3871801 | Predose up to Day 7 post dose | Total Number of Metabolites of LY3871801 |
| Total Radioactivity Recovered in Urine, Feces, and Expired Air | Predose up to Day 7 post dose | Total Radioactivity Recovered in Urine, Feces, and Expired Air |
| PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood | Predose up to Day 7 post dose | PK: AUC \[0-∞\] of Total Radioactivity in Plasma and Whole Blood |
Countries
United States
Outcome results
None listed