Healthy
Conditions
Brief summary
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.
Interventions
DRUGLY3214996
Administered orally
DRUG[14C]-LY3214996
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly health males * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Exclusion criteria
* Females * Male participants sexually active with a pregnant partner * Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study * Have participated in a radiolabeled drug study within the previous 4 months * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders * Have a history of Gilbert's syndrome * Have history or presence of psychiatric disorders * Show evidence of human immunodeficiency virus (HIV) infection * Show evidence of hepatitis C * Show evidence of hepatitis B
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through Day 8 after administration of study drug | Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
| Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through Day 8 after administration of study drug | Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996 | Predose through Day 8 after administration of study drug | PK: Cmax of LY3214996 |
| PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996 | Predose through Day 8 after administration of study drug | PK: AUC(0-∞) of LY3214996 |
| Total Number of Metabolites of LY3214996 | Baseline through 48 hours after administration of study drug | Total Number of Metabolites of LY3214996 |
Countries
United States
Outcome results
None listed