HealthyPhase 1NCT07867327
A Study of LY4515100 in Healthy Male Participants
A Phase 1 study testing [¹⁴C]-LY4515100 Oral Solution, LY4515100 Tablet and [¹⁴C]-LY4515100 IV in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate how the body handles [¹⁴C]-LY4515100. The study will investigate how much [¹⁴C]-LY4515100 enters the bloodstream from the stomach or intestines and is available to have an effect on the body, how the body changes [¹⁴C]-LY4515100 so that it can be used or removed, and how… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [¹⁴C]-LY4515100 Oral Solution, LY4515100 Tablet and [¹⁴C]-LY4515100 IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are overtly healthy as determined by medical evaluation.
- Have a body mass index (BMI) within the range of 18.0 to 35.0 kilograms per square meter (kg/m²), inclusive.
Who cannot join
- Have significant previous or current history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinal, hematological, neurological, thromboembolism, or bleeding disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study intervention; or of interfering with the interpretation of data.
- Have a significant history of or current psychiatric disorders.
- Have history of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs. Uncomplicated appendectomy and hernia repair will be allowed.
- Have a history of constipation or have had acute constipation within 3 weeks prior to check-in.
- Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing, for example, serial x-ray or computed tomography scans, barium meal, or current employment in a job requiring radiation exposure monitoring.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States1 site
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
608-442-8200
Kimberly Cruz
About this study
Official title: A Phase 1, Open-Label, 2-Part Study of the Absorption, Metabolism, Excretion, and Bioavailability of [¹⁴C]-LY4515100 in Healthy Male Participants
The main purpose of this study is to evaluate how the body handles [¹⁴C]-LY4515100. The study will investigate how much [¹⁴C]-LY4515100 enters the bloodstream from the stomach or intestines and is available to have an effect on the body, how the body changes [¹⁴C]-LY4515100 so that it can be used or removed, and how the body gets rid of [¹⁴C]-LY4515100. For each participant, the study will last about 9 weeks and will include a Clinical Research Unit (CRU) stay lasting between 10 and 30 days.
- Conditions
- Healthy
- Being tested
- [¹⁴C]-LY4515100 Oral Solution, LY4515100 Tablet, [¹⁴C]-LY4515100 IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]-LY4515100 Oral SolutionDrug
[¹⁴C]-LY4515100 administered orally
LY4515100 TabletDrug
LY4515100 administered orally
[¹⁴C]-LY4515100 IVDrug
[¹⁴C]-LY4515100 administered IV
| Study group | Role | What they receive |
|---|---|---|
| [¹⁴C]-LY4515100 Part 1 | Experimental | [¹⁴C]-LY4515100 containing radioactivity administered orally Receives: Drug: [¹⁴C]-LY4515100 Oral Solution |
| LY4515100 + [¹⁴C]-LY4515100 Part 2 | Experimental | LY4515100 administered orally with [¹⁴C]-LY4515100 containing radioactivity administered intravenously (IV) Receives: Drug: LY4515100 Tablet; Drug: [¹⁴C]-LY4515100 IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Urinary Excretion of [¹⁴C]-LY4515100 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Predose Up to Day 14
Part 1: Fecal Excretion of [¹⁴C]-LY4515100 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Predose Up to Day 14
Part 2: Dose Normalized Ratio of the Area Under the Concentration-Time Curve After Oral Administration (AUCpo) to Area Under the Concentration-Time Curve After Intravenous Administration (AUCiv) of LY4515100
Measured: Predose Up to Day 14
Secondary outcomes (8)
Part 1: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity
Measured: Predose Up to Day 14
Part 1: PK: Maximum Concentration (Cmax) of Total Plasma Radioactivity
Measured: Predose Up to Day 14
Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air
Measured: Predose Up to Day 14
Part 1: Total Number of Metabolites of LY4515100 in Urine, Feces, and Plasma
Measured: Predose Up to Day 14
Part 2: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of [¹⁴C]-LY4515100
Measured: Predose Up to Day 9
Part 2: PK: Maximum Concentration (Cmax) of [¹⁴C]-LY4515100
Measured: Predose Up to Day 9
Part 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity
Measured: Predose Up to Day 9
Part 2: PK: Maximum Concentration (Cmax) of Total Plasma Radioactivity
Measured: Predose Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867327
- Sponsor's protocol ID
- 27791
- Other IDs
- J6V-MC-OIAC
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No