NCT06644378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

October 15, 2024

Last Update Submit

January 21, 2025

Conditions

Healthy

Keywords

RadioactiveADMEDispositionBioavailability

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

Secondary Outcomes (12)

  • 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 LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288

    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

    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

  • +7 more secondary outcomes

Study Arms (2)

Part A: [14C]-LY3866288

EXPERIMENTAL

Single dose of \[¹⁴C\]-LY3866288 administered orally.

Drug: [14C]-LY3866288

Part B: LY3866288 + [14C]-LY3866288

EXPERIMENTAL

Single dose of LY3866288 administered orally followed by a single dose of \[¹⁴C\]-LY3866288 administered intravenously (IV).

Drug: LY3866288Drug: [14C]-LY3866288

Interventions

[14C]-LY3866288DRUG

Administered orally.

Part A: [14C]-LY3866288
LY3866288DRUG

Administered orally.

Part B: LY3866288 + [14C]-LY3866288

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 16, 2024

Study Start

October 28, 2024

Primary Completion

January 3, 2025

Study Completion

January 3, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)