Clinical trial NCT06644378: A Study of [14C]-LY3866288 in Healthy Participants
Official title: A Phase 1, Open-label, 2-part Study of the Absorption, Metabolism, and Excretion, and Absolute Bioavailability of [14C]-LY3866288 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Radioactive
ADME
Disposition
Bioavailability
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 21 postdose
measure: Part A, Fraction of Dose [14C]-LY3866288 Excreted in Feces Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 21 postdose
measure: Part B, Absolute Bioavailability (Fabs) of LY3866288
timeFrame: Predose up to Day 9 postdose
Secondary outcomes:
measure: 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
timeFrame: Predose up to Day 7 postdose
measure: 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
timeFrame: Predose up to Day 21 postdose
measure: Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288
timeFrame: Predose up to Day 7 postdose
measure: Part A: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood Following a Single Oral Dose of [14C]-LY3866288
timeFrame: Predose up to Day 21 postdose
measure: Part A: PK: Ratio of AUC0-inf of Plasma LY3866288 to AUC0-inf of Plasma Total Radioactivity
timeFrame: Predose up to Day 21 postdose
measure: Part A: PK: Ratio of AUC0-inf of Whole Blood Total Radioactivity to AUC0-inf of Plasma Total Radioactivity
timeFrame: Predose up to Day 21 postdose
measure: Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma
timeFrame: Predose up to Day 9 postdose
measure: Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of [14C]-LY3866288 in Plasma
timeFrame: Predose up to Day 9 postdose
measure: Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma
timeFrame: Predose up to Day 9 postdose
measure: Part B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma
timeFrame: Predose up to Day 9 postdose
measure: Part B: PK: Maximum Observed Plasma Concentration (Cmax) of [14C]-LY3866288 in Plasma
timeFrame: Predose up to Day 9 postdose
measure: Part B: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma
timeFrame: Predose up to Day 9 postdose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: