A Phase 1, Open-label, 2-part Study of the Absorption, Metabolism, and Excretion, and Absolute Bioavailability of [14C]-LY3866288 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- [14C]-LY3866288
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Part A: [14C]-LY3866288
Single dose of \[¹⁴C\]-LY3866288 administered orally.
Intervention: [14C]-LY3866288
Part B: LY3866288 + [14C]-LY3866288
Single dose of LY3866288 administered orally followed by a single dose of \[¹⁴C\]-LY3866288 administered intravenously (IV).
Intervention: LY3866288
Part B: LY3866288 + [14C]-LY3866288
Single dose of LY3866288 administered orally followed by a single dose of \[¹⁴C\]-LY3866288 administered intravenously (IV).
Intervention: [14C]-LY3866288
Outcomes
Primary Outcomes
Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered
Time Frame: Predose up to Day 21 postdose
Part A, Fraction of Dose [14C]-LY3866288 Excreted in Feces Expressed as a Percentage of the Total Radioactive Dose Administered
Time Frame: Predose up to Day 21 postdose
Part B, Absolute Bioavailability (Fabs) of LY3866288
Time Frame: Predose up to Day 9 postdose
Secondary Outcomes
- 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)
- 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 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 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 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 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)