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Completed

NCT Number: NCT06644378

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]-LY3866288

Drug

Administered orally.

LY3866288

Drug

Administered orally.

Primary outcomes

  1. 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

  2. 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

  3. Part B, Absolute Bioavailability (Fabs) of LY3866288

    Time frame: Predose up to Day 9 postdose

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Part A: PK: Ratio of AUC0-inf of Whole Blood Total Radioactivity to AUC0-inf of Plasma Total Radioactivity

    Time frame: Predose up to Day 21 postdose

  7. Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma

    Time frame: Predose up to Day 9 postdose

  8. Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of [14C]-LY3866288 in Plasma

    Time frame: Predose up to Day 9 postdose

  9. Part B: PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma

    Time frame: Predose up to Day 9 postdose

  10. Part B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma

    Time frame: Predose up to Day 9 postdose

  11. Part B: PK: Maximum Observed Plasma Concentration (Cmax) of [14C]-LY3866288 in Plasma

    Time frame: Predose up to Day 9 postdose

  12. Part B: PK: Maximum Observed Plasma Concentration (Cmax) of Total Radioactivity in Plasma

    Time frame: Predose up to Day 9 postdose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Open-label, 2-part Study of the Absorption, Metabolism, and Excretion, and Absolute Bioavailability of [14C]-LY3866288 in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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