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HealthyPhase 1NCT06644378

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

A Phase 1 study testing [14C]-LY3866288 and LY3866288 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
[14C]-LY3866288 and LY3866288
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
28 Oct 2024to 3 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Open-label, 2-part Study of the Absorption, Metabolism, and Excretion, and Absolute Bioavailability 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.

Conditions
Healthy
Being tested
[14C]-LY3866288, LY3866288
Keywords
Radioactive, ADME, Disposition, Bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-LY3866288Drug

    Administered orally.

  • LY3866288Drug

    Administered orally.

  • [14C]-LY3866288Drug

    Administered IV.

Study groups in NCT06644378
Study groupRoleWhat they receive
Part A: [14C]-LY3866288ExperimentalSingle dose of [¹⁴C]-LY3866288 administered orally.
Receives: Drug: [14C]-LY3866288
Part B: LY3866288 + [14C]-LY3866288ExperimentalSingle dose of LY3866288 administered orally followed by a single dose of [¹⁴C]-LY3866288 administered intravenously (IV).
Receives: Drug: LY3866288; Drug: [14C]-LY3866288

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered

    Measured: 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

    Measured: Predose up to Day 21 postdose

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

    Measured: Predose up to Day 9 postdose

Secondary outcomes (12)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Predose up to Day 21 postdose

  5. Part A: PK: Ratio of AUC0-inf of Plasma LY3866288 to AUC0-inf of Plasma Total Radioactivity

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Predose up to Day 9 postdose

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

    Measured: Predose up to Day 9 postdose

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

    Measured: Predose up to Day 9 postdose

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

    Measured: Predose up to Day 9 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start28 Oct 2024
  3. Primary completion3 Jan 2025
  4. Study completion3 Jan 2025

Resources

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
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644378
Sponsor's protocol ID
18885
Other IDs
J4G-OX-JZVB
Status last verified
Jan 2025
First submitted
15 Oct 2024
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-LY3866288 and LY3866288 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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