HealthyPhase 1NCT06052462
A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants
A Phase 1 study testing [14C]-LY3556050 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 much of the study drug (LY3556050), 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 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-LY3556050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 4 Nov 2023
- 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
- 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 32.0 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 LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy
- Have clinically significant abnormal BP and/or pulse rate as determined by the investigator
- Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disposition of [14C]-LY3556050 Following Oral Administration in Healthy Male Participants
The main purpose of this study is to evaluate how much of the study drug (LY3556050), 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, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.
- Conditions
- Healthy
- Being tested
- [14C]-LY3556050
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-LY3556050Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| [14C]-LY3556050 | Experimental | Single dose of [¹⁴C]-LY3556050 administered orally Receives: Drug: [14C]-LY3556050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Predose up to Day 21 post dose
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Predose up to Day 21 post dose
Secondary outcomes (8)
Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma
PK: AUC(0-tlast) of LY3556050 in Plasma
Measured: Predose up to Day 21 post dose
PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood
PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood
Measured: Predose up to Day 21 post dose
PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma
PK: AUC (0-∞) of LY3556050 in Plasma
Measured: Predose up to Day 21 post dose
PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood
PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood
Measured: Predose up to Day 21 post dose
PK: Maximum Concentration (Cmax) of LY3556050 in Plasma
PK: Cmax of LY3556050 in Plasma
Measured: Predose up to Day 21 post dose
PK: Cmax of Total Radioactivity in Plasma and Blood
PK: Cmax of Total Radioactivity in Plasma and Blood
Measured: Predose up to Day 21 post dose
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Measured: Predose up to Day 7 post dose
Total Number of Metabolites of LY3556050
Total Number of Metabolites of LY3556050
Measured: Predose up to Day 7 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start20 Sep 2023
- Primary completion4 Nov 2023
- Study completion4 Nov 2023
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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052462
- Sponsor's protocol ID
- 18347
- Other IDs
- J2P-MC-LXBC
- Status last verified
- Jan 2024
- First submitted
- 18 Sep 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C]-LY3556050 Following Oral Administration in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06052462
- Acronym / sponsor ID
- 18347
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate how much of the study drug (LY3556050), 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, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-LY3556050 | Experimental | Drug: [14C]-LY3556050Single dose of [¹⁴C]-LY3556050 administered orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male participants who are overtly healthy as determined by medical evaluation
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive
- Males who agree to use highly effective or effective methods of contraception
Key exclusion criteria (3 listed)
- Have known allergies to LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy
- Have clinically significant abnormal BP and/or pulse rate as determined by the investigator
- Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-LY3556050Administered orally | Drug | [14C]-LY3556050 |
Primary outcome
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose up to Day 21 post dose
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose up to Day 21 post dose
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
8 secondary outcomes
Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma
Time frame: Predose up to Day 21 post dose
PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood
Time frame: Predose up to Day 21 post dose
PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma
Time frame: Predose up to Day 21 post dose
PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood
Time frame: Predose up to Day 21 post dose
PK: Maximum Concentration (Cmax) of LY3556050 in Plasma
Time frame: Predose up to Day 21 post dose
PK: Cmax of Total Radioactivity in Plasma and Blood
Time frame: Predose up to Day 21 post dose
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)
Time frame: Predose up to Day 7 post dose
Total Number of Metabolites of LY3556050
Time frame: Predose up to Day 7 post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-LY3556050 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 3 inclusion and 3 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 5 Jan 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 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?
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Predose up to Day 21 post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.