A Study of [14C]-LY3866288 in Healthy Participants (NCT06644378) | Clinical Trial Compass
CompletedPhase 1
A Study of [14C]-LY3866288 in Healthy Participants
United States15 participantsStarted 2024-10-28
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
Part B, Absolute Bioavailability (Fabs) of LY3866288