Healthy
Conditions
Keywords
Radiolabeled Drug
Brief summary
The main purpose of this study is to evaluate how much of the study drug (LY3372689), 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 about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
Interventions
DRUG[¹⁴C]-LY3372689
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 within the range 18.5 to 32.0 kilograms per meter squared (kg/m²) * Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose of LY3372689 may participate in this trial.
Exclusion criteria
* Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in * Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Have evidence of significant active neuropsychiatric disease, as determined by the investigator * Have participated in \>3 radiolabeled drug studies in the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 17 post dose | Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
| Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 17 post dose | Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689 | Predose up to Day 17 post dose | PK: AUC (0-tlast) of Total Radioactivity and \[¹⁴C\]-LY3372689 |
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689 | Predose up to Day 17 post dose | PK: AUC (0-∞) of Total Radioactivity and \[¹⁴C\]-LY3372689 |
| Total Number of Metabolites of LY3372689 | Predose up to 120 hour post dose | Total Number of Metabolites of LY3372689 |
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Predose up to Day 17 post dose | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) |
| PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689 | Predose up to Day 17 post dose | PK: Cmax of Total Radioactivity and \[¹⁴C\]-LY3372689 |
Countries
United States
Outcome results
None listed