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HealthyPhase 1NCT06342596

A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants

A Phase 1 study testing [14C]-LY3473329 and LY3473329 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.

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 (LY3473329), 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 male participants. Read more about this study

Who is it for?
Ages 35 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
[14C]-LY3473329 and LY3473329
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited Kingdom
Study dates
5 Mar 2024to 1 May 2024
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 35 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male participants who are overtly healthy as determined by medical evaluation
  • Have a body mass index of 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive
  • Males who agree to use highly effective or effective methods of contraception

Who cannot join

  • Have known allergies to LY3473329, related compounds, or any components of the formulation, or history of significant atopy
  • Have a history of constipation or have had acute constipation within 3 weeks prior to check-in
  • Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in. Any previous radiolabeled study intervention must have been received more than 12 months prior to check-in
  • Have used or plan to use over-the-counter or prescription medication within 14 days prior to dosing, or any medications or products known to alter drug absorption, metabolism, or elimination processes
  • Have participated, within the last 3 months, in a clinical study involving an investigational product

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Fortrea Clinical Research Unit

    Holbeck, Leeds, LS11 9EH

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3473329), 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 male 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 is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.

Conditions
Healthy
Being tested
[14C]-LY3473329, LY3473329
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]-LY3473329Drug

    Administered orally

  • [14C]-LY3473329Drug

    Administered IV

  • LY3473329Drug

    Administered orally

Study groups in NCT06342596
Study groupRoleWhat they receive
[14C]-LY3473329 (Part 1)ExperimentalSingle dose of [¹⁴C]-LY3473329 administered orally
Receives: Drug: [14C]-LY3473329
LY3473329 + [14C]-LY3473329 (Part 2)ExperimentalSingle dose of LY3473329 administered orally followed by a single dose of [¹⁴C]-LY3473329 administered intravenously (IV)
Receives: Drug: [14C]-LY3473329; Drug: LY3473329

What is being measured

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

  1. Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Measured: Day 1 up to Day 29 post dose

  2. Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Measured: Day 1 up to Day 29 post dose

  3. Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329

    Part 2: PK: F of LY3473329

    Measured: Day 1 up to Day 9 post dose

Secondary outcomes (15)

  1. Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329

    Part 1: PK: AUC(0-tlast) of LY3473329

    Measured: Day 1 up to Day 29 post dose

  2. Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity

    Part 1: PK: AUC(0-tlast) of Total Radioactivity

    Measured: Day 1 up to Day 29 post dose

  3. Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329

    Part 1: PK: AUC(0-∞) of LY3473329

    Measured: Day 1 up to Day 29 post dose

  4. Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity

    Part 1: PK: AUC(0-∞) of Total Radioactivity

    Measured: Day 1 up to Day 29 post dose

  5. Part 1: PK: Maximum Concentration (Cmax) of LY3473329

    Part 1: PK: Cmax of LY3473329

    Measured: Day 1 up to Day 29 post dose

  6. Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity

    Part 1: PK: Cmax of Total Radioactivity

    Measured: Day 1 up to Day 29 post dose

  7. Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)

    Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)

    Measured: Day 1 up to Day 29 post dose

  8. Part 1: Total Number of Metabolites of LY3473329

    Part 1: Total Number of Metabolites of LY3473329

    Measured: Day 1 up to Day 29 post dose

  9. Part 2: PK: AUC (0-∞) of LY3473329

    Part 2: PK: AUC (0-∞) of LY3473329

    Measured: Day 1 up to Day 9 post dose

  10. Part 2: PK: AUC (0-∞) of [14C]-LY3473329

    Part 2: PK: AUC (0-∞) of [14C]-LY3473329

    Measured: Day 1 up to Day 9 post dose

  11. Part 2: PK: AUC (0-∞) of Total Radioactivity

    Part 2: PK: AUC (0-∞) of Total Radioactivity

    Measured: Day 1 up to Day 9 post dose

  12. Part 2: PK: Cmax of LY3473329

    Part 2: PK: Cmax of LY3473329

    Measured: Day 1 up to Day 9 post dose

  13. Part 2: PK: Cmax of [14C]-LY3473329

    Part 2: PK: Cmax of [14C]-LY3473329

    Measured: Day 1 up to Day 9 post dose

  14. Part 2: PK: Cmax of Total Radioactivity

    Part 2: PK: Cmax of Total Radioactivity

    Measured: Day 1 up to Day 9 post dose

  15. Part 2: Total Radioactivity Recovered in Urine and Feces

    Part 2: Total Radioactivity Recovered in Urine and Feces

    Measured: Day 1 up to Day 9 post dose

Timeline

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

  1. First posted2 Apr 2024
  2. Study start5 Mar 2024
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

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
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342596
Sponsor's protocol ID
18597
Other IDs
J2O-MC-EKBD
Status last verified
May 2024
First submitted
26 Feb 2024
Last updated
30 May 2024
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]-LY3473329 and LY3473329 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.

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 3 inclusion and 5 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 30 May 2024. 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 Kingdom. 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 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Day 1 up to Day 29 post dose). 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 NCT06342596.

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 30 May 2024.

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Clinical Trial NCT06342596 | AzTrials