Healthy MalePhase 1NCT06194500

A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants

A Phase 1 study testing [14C]-LY3549492 and LY3549492 in people with Healthy Male, 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

Search all trials

Trial summary

Who is it for?: Ages 35 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male
What is being tested?: [14C]-LY3549492 and LY3549492
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited Kingdom
Study dates: 3 Jan 2024to 15 Feb 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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
Participants who have safety laboratory test results within normal reference ranges, or results with acceptable deviations that are deemed not clinically significant by the investigator.
Body mass index (BMI) within the range of 20.0 to 40.0 kilograms per meter squared (kg/m2), inclusive.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Who cannot join

Have known allergies to LY3549492, glucagon-like peptide-1 (GLP-1) non-peptide agonist (NPA)-related compounds or any components of the formulation as appropriate, or history of atopy.
Have a clinical diagnosis of a long QT syndrome.
Have any abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participation in the study or may confound ECG data analysis.
Have significant history of any current serious medical condition.
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or have an elevation in serum amylase or lipase (>1.0×Upper Limit Normal (ULN)).

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: An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [14C]-LY3549492 in Healthy Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will be conducted in healthy males and has two parts. In Part A, participants will receive carbon-14 (14C) radiolabeled LY3549492 ([14C] LY3549492) given by mouth. In Part B, participants will receive LY3549492 by mouth. Three hours later, participants will receive [14C] LY3549492 given into a vein.

The radioactive substance C14 will be incorporated into the study drug to investigate the study drug and breakdown products to find out how much of these passes from blood into urine, stool, and breath.

The study will last about 2 months in Part A and about 1½ months in Part B. This includes screening, treatment, and follow-up visits.

Conditions: Healthy Male
Being tested: [14C]-LY3549492, LY3549492

What participants receive

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

[14C]-LY3549492Drug
Administered as oral solution.
LY3549492Drug
Administered orally.
[14C]-LY3549492Drug
Administered as IV infusion.

Study groups in NCT06194500
Study group	Role	What they receive
Carbon-14-Labeled [14C]-LY3549492 - Part A	Experimental	Carbon-14-Labeled [14C]-LY3549492 administered as oral solution. Receives: Drug: [14C]-LY3549492
LY3549492 + [14C]-LY3549492 - Part B	Experimental	LY3549492 administered as oral solution followed 3 hours later by [14C] LY3549492 will be administered as intravenous (IV) infusion. Receives: Drug: LY3549492; Drug: [14C]-LY3549492

What is being measured

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

Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose
Measured: Predose up to Day 24 postdose in Part A
Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total
Measured: Predose up to Day 24 postdose in Part A
Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B
PK: AUC for oral determination of absolute bioavailability (F) of LY3549492
Measured: Predose up to Day 7 postdose in Part B
PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B
PK: AUC for IV determination of absolute bioavailability (F) of LY3549492
Measured: Predose up to Day 7 postdose in Part B

Secondary outcomes (9)

PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A
PK: AUC for radioactivity
Measured: Predose up to Day 24 postdose in Part A
PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A
PK: Cmax for radioactivity
Measured: Predose up to Day 24 postdose in Part A
PK: AUC of LY3549492 in Plasma in Part A
PK: AUC of LY3549492 in plasma
Measured: Predose up to Day 24 postdose in Part A
PK: Cmax of LY3549492 in Plasma in Part A
PK: Cmax of LY3549492 in plasma
Measured: Predose up to Day 24 postdose in Part A
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A
Total radioactivity recovered in urine, feces, and expired air (if applicable) in Part A
Measured: Predose up to Day 24 postdose in Part A
Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A
Total number of metabolites and identification of metabolites of LY3549492
Measured: Predose up to Day 24 postdose in Part A
PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B
AUC of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B
Measured: Predose up to Day 7 postdose in Part B
PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B
Cmax of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B
Measured: Predose up to Day 7 postdose in Part B
Total Radioactivity Recovered in Urine and Feces in Part B
Total radioactivity recovered in urine and feces in Part B
Measured: Predose up to Day 7 postdose in Part B

Timeline

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

3 Jan 202415 Feb 2024

First posted8 Jan 2024
Study start3 Jan 2024
Primary completion15 Feb 2024
Study completion15 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy MaleStudies 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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06194500
Sponsor's protocol ID: 18348
Other IDs: J3H-MC-GZNC, U1111-1293-8652
Status last verified: Mar 2024
First submitted: 20 Dec 2023
Last updated: 28 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Healthy Male Participants

All Healthy Male trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [14C]-LY3549492 in Healthy Participants
ClinicalTrials.gov ID: NCT06194500
Acronym / sponsor ID: 18348
Conditions: Healthy Male
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 3 Jan 2024 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 15 Feb 2024 (actual)
First posted: 8 Jan 2024 (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 study will last about 2 months in Part A and about 1½ months in Part B. This includes screening, treatment, and follow-up visits.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Carbon-14-Labeled [14C]-LY3549492 - Part A	Experimental	Drug: [14C]-LY3549492Carbon-14-Labeled [14C]-LY3549492 administered as oral solution.
LY3549492 + [14C]-LY3549492 - Part B	Experimental	Drug: LY3549492, Drug: [14C]-LY3549492LY3549492 administered as oral solution followed 3 hours later by [14C] LY3549492 will be administered as intravenous (IV) infusion.

Who may qualify

Ages: 35 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
Participants who have safety laboratory test results within normal reference ranges, or results with acceptable deviations that are deemed not clinically significant by the investigator.
Body mass index (BMI) within the range of 20.0 to 40.0 kilograms per meter squared (kg/m2), inclusive.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key exclusion criteria (5 listed)

Have known allergies to LY3549492, glucagon-like peptide-1 (GLP-1) non-peptide agonist (NPA)-related compounds or any components of the formulation as appropriate, or history of atopy.
Have a clinical diagnosis of a long QT syndrome.
Have any abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participation in the study or may confound ECG data analysis.
Have significant history of any current serious medical condition.
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or have an elevation in serum amylase or lipase (>1.0×Upper Limit Normal (ULN)).

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]-LY3549492Administered as oral solution.	Drug	Carbon-14-Labeled [14C]-LY3549492 - Part A
LY3549492Administered orally.	Drug	LY3549492 + [14C]-LY3549492 - Part B
[14C]-LY3549492Administered as IV infusion.	Drug	LY3549492 + [14C]-LY3549492 - Part B

Primary outcome

Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
Time frame: Predose up to Day 24 postdose in Part A
Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose
Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A
Time frame: Predose up to Day 24 postdose in Part A
Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total
Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B
Time frame: Predose up to Day 7 postdose in Part B
PK: AUC for oral determination of absolute bioavailability (F) of LY3549492
PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B
Time frame: Predose up to Day 7 postdose in Part B
PK: AUC for IV determination of absolute bioavailability (F) of LY3549492

9 secondary outcomes

PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A
Time frame: Predose up to Day 24 postdose in Part A
PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A
Time frame: Predose up to Day 24 postdose in Part A
PK: AUC of LY3549492 in Plasma in Part A
Time frame: Predose up to Day 24 postdose in Part A
PK: Cmax of LY3549492 in Plasma in Part A
Time frame: Predose up to Day 24 postdose in Part A
Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A
Time frame: Predose up to Day 24 postdose in Part A
Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A
Time frame: Predose up to Day 24 postdose in Part A
PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B
Time frame: Predose up to Day 7 postdose in Part B
PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B
Time frame: Predose up to Day 7 postdose in Part B
Total Radioactivity Recovered in Urine and Feces in Part B
Time frame: Predose up to Day 7 postdose in Part B

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 28 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Healthy Male

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
Evaluate the Effect of Vimseltinib on P-glycoprotein (P-gp) Inhibition in Healthy Male Participants
Healthy Male Participants

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]-LY3549492 and LY3549492 in people with Healthy Male, 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 4 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 28 Mar 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?

Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A (time frame: Predose up to Day 24 postdose in Part A). The study lists 4 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 NCT06194500.

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 28 Mar 2024.