A Study of [14C]-LY3866288 in Healthy Participants

Eli Lilly and Company15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[14C]-LY3866288DRUG

Administered orally.

LY3866288DRUG

Administered orally.

[14C]-LY3866288DRUG

Administered IV.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

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: 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

Time frame: 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

Time frame: 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

Time frame: Predose up to Day 7 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

Time frame: Predose up to Day 21 postdose

Part A: PK: Ratio of AUC0-inf of Plasma LY3866288 to AUC0-inf of Plasma Total Radioactivity

Time frame: Predose up to Day 21 postdose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.