LY3866288 for Healthy Subjects

Overseen By This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Pregnancy, Drug abuse, Significant diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for healthy men and women with a BMI between 18.0 and 32.0 kg/m^2, who pass medical exams including ECGs and lab tests. Men must be infertile (via surgery), while non-childbearing women must use contraception.

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)

I am a male and infertile due to having had surgery.

I am a woman not able to bear children and I use birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Part A: Treatment

Single dose of [14C]-LY3866288 administered orally to evaluate absorption, metabolism, and excretion

Approximately 4 weeks

1 visit (in-patient)

Part B: Treatment

Single dose of LY3866288 administered orally followed by a single dose of [14C]-LY3866288 administered intravenously

Approximately 4 weeks

1 visit (in-patient)

Follow-up

Participants are monitored for safety and tolerability after treatment

4 weeks

Treatment Details

Interventions

• [14C]-LY3866288
• LY3866288

Trial Overview [14C]-LY3866288, a study drug marked with radioactive carbon (14C), is being tested to see how it's processed by the body when taken orally or injected into the vein—how much enters blood, urine, feces, air expelled from lungs, its breakdown and elimination time.

Participant Groups

Group I: Part B: LY3866288 + [14C]-LY3866288 Experimental Treatment 2 Interventions

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

Group II: Part A: [14C]-LY3866288 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University