Healthy
Conditions
Keywords
Radioactive, ADME, Disposition, Bioavailability
Brief summary
The main purpose of this study is to evaluate how much of the study drug (LY3866288), 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 participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study will also evaluate the safety and tolerability of LY3866288.The study is conducted in two parts. The study is expected to last approximately 68 days.
Interventions
DRUG[14C]-LY3866288
Administered orally.
DRUGLY3866288
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants who are overtly healthy determined by medical history, physical examination, 12-lead ECGs, vital signs measurements, and clinical laboratory evaluations at screening and/or check-in by the investigator * Have Body mass index between 18.0 and 32.0 kg/m\^2 (kilograms per meter squared) * Male participants who are infertile via bilateral orchiectomy or vasectomy * Female participants (non-childbearing potential only for Part A) who follow standard contraceptive methods
Exclusion criteria
* Female participants who are lactating or pregnant * Have history of alcohol and/or drug abuse within 2 years prior to screening * Have history or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor * Have history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A, Fraction of Dose [14C]-LY3866288 Excreted in Feces Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 postdose |
| Part B, Absolute Bioavailability (Fabs) of LY3866288 | Predose up to Day 9 postdose |
| Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 postdose |
Secondary
| Measure | Time frame |
|---|---|
| Part A: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 21 postdose |
| Part A: PK: Ratio of AUC0-inf of Plasma LY3866288 to AUC0-inf of Plasma Total Radioactivity | Predose up to Day 21 postdose |
| Part A: PK: Ratio of AUC0-inf of Whole Blood Total Radioactivity to AUC0-inf of Plasma Total Radioactivity | Predose up to Day 21 postdose |
| Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part A: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 7 postdose |
| Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Maximum Observed Plasma Concentration (Cmax) of [14C]-LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma | Predose up to Day 9 postdose |
| Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of [14C]-LY3866288 in Plasma | Predose up to Day 9 postdose |
| Part A: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma and Whole Blood Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 21 postdose |
| Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288 | Predose up to Day 7 postdose |
Countries
United States
Outcome results
None listed