HealthyPhase 1NCT07519525
A Study of [14C]-LY4064809 in Healthy Participants
A Phase 1 study testing LY4064809 and [14C]-LY4064809 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to determine in healthy participants the percentage of LY4064809 that enters bloodstream after oral administration. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 21 days, not including screening. 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?
- LY4064809 and [14C]-LY4064809
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 26 May 2026
- 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
- Must be healthy as shown by medical history, physical examination, laboratory tests and heart monitoring
- Must have normal blood pressure and pulse rate
- Must have a history of a minimum of 1 bowel movement per day
- Must have body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2)
- Must be healthy men or healthy women who are not of childbearing potential
- Healthy men with partners who can become pregnant must remain abstinent or use contraceptives consistent with local regulations
Who cannot join
- Must not have a significant history or presence of metabolic disease, heart, liver, gallbladder, bile ducts, digestive, blood or nervous system disorders that could affect the way the body absorbs and processes the study drug
- Must not have an abnormal electrocardiogram (ECG)
- Must not have a history of major surgery within 30 days of entering study
- Must not have a history of cancer within 5 years of screening
- Must not have known allergies to LY4064809 or related compounds
- Must not have history of multiple or severe drug reactions or allergies which required treatment with steroids or epinephrine
Show all 16Show fewer
- Must not have history or presence of psychiatric conditions that would prevent the participant from following study instructions.
- Must not use medications, except acetaminophen within 14 days of the first dose of LY4064809 and during the clinic stay
- Must not have participated in and been dosed in more than 2 radiolabeled drug studies in the last 12 months
- Must not have had exposure to significant diagnostic, therapeutic or employment-related radiation within 12 months
- Must not have participated in any other radiolabeled investigational study drug trial within 6 months prior to admission.
- Must not show evidence of human immunodeficiency Virus (HIV) infection or positive HIV-1 and HIV-2 antibodies
- Must not have evidence of Hepatitis C virus (HCV) infection or a positive HCV antibody test.
- Must not have evidence of Hepatitis B virus (HBV) infection or a positive Hepatitis B surface antigen (HBsAg)
- Must not have alcohol intake deemed significant by the investigator
- Must not use tobacco, smoking-cessation products, e-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to LY4064809 administration and discharge from the clinical research unit (CRU) or early termination (ET)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
About this study
Official title: A Phase 1, Open-label Study of the Absolute Bioavailability of [14C]-LY4064809 in Healthy Adult Participants
The purpose of this study is to determine in healthy participants the percentage of LY4064809 that enters bloodstream after oral administration. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 21 days, not including screening. Participants will remain in the clinical research center for 14 days.
- Conditions
- Healthy
- Being tested
- LY4064809, [14C]-LY4064809
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4064809Drug
Administered orally
[14C]-LY4064809Drug
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| LY4064809 | Experimental | Not described Receives: Drug: LY4064809; Drug: [14C]-LY4064809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the absolute bioavailability (F) of LY4064809 following administration of a single oral dose compared to an intravenous reference dose in healthy participants.
Measured: Baseline up to Day 14
Secondary outcomes (4)
Pharmacokinetics (PK): Plasma Maximum Concentration (Cmax) of LY4064809
PK: Plasma Cmax of LY4064809
Measured: Baseline up to Day 14
PK of Total Radioactivity: Plasma Area Under the Concentration Versus Time Curve (AUC) of [14C]-LY4064809
PK of Total Radioactivity: Plasma AUC
Measured: Baseline up to Day 14
Excretion and Recovery of Total Radioactivity in Urine
Investigate the rate and routes of excretion, including the mass balance in urine after dosing.
Measured: Baseline up to Day 13
Excretion and Recovery of Total Radioactivity and [14C] LY4064809 in Feces
Investigate the rate and routes of excretion, including the mass balance in feces
Measured: Baseline up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start27 Mar 2026
- Primary completion26 May 2026
- Study completion26 May 2026
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
- Not applicable
- 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519525
- Sponsor's protocol ID
- 27776
- Other IDs
- J6M-MC-JSGF
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absolute Bioavailability of [14C]-LY4064809 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07519525
- Acronym / sponsor ID
- 27776
- 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
- 27 Mar 2026 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 9 Apr 2026 (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 purpose of this study is to determine in healthy participants the percentage of LY4064809 that enters bloodstream after oral administration. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 21 days, not including screening. Participants will remain in the clinical research center for 14 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY4064809 | Experimental | Drug: LY4064809, Drug: [14C]-LY4064809 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be healthy as shown by medical history, physical examination, laboratory tests and heart monitoring
- Must have normal blood pressure and pulse rate
- Must have a history of a minimum of 1 bowel movement per day
- Must have body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2)
- Must be healthy men or healthy women who are not of childbearing potential
Key exclusion criteria (16 listed)
- Must not have a significant history or presence of metabolic disease, heart, liver, gallbladder, bile ducts, digestive, blood or nervous system disorders that could affect the way the body absorbs and processes the study drug
- Must not have an abnormal electrocardiogram (ECG)
- Must not have a history of major surgery within 30 days of entering study
- Must not have a history of cancer within 5 years of screening
- Must not have known allergies to LY4064809 or related compounds
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 |
|---|---|---|
| LY4064809Administered orally | Drug | LY4064809 |
| [14C]-LY4064809Administered by IV infusion | Drug | LY4064809 |
Primary outcome
To determine the absolute bioavailability (F) of LY4064809 following administration of a single oral dose compared to an intravenous reference dose in healthy participants.
Time frame: Baseline up to Day 14
4 secondary outcomes
Pharmacokinetics (PK): Plasma Maximum Concentration (Cmax) of LY4064809
Time frame: Baseline up to Day 14
PK of Total Radioactivity: Plasma Area Under the Concentration Versus Time Curve (AUC) of [14C]-LY4064809
Time frame: Baseline up to Day 14
Excretion and Recovery of Total Radioactivity in Urine
Time frame: Baseline up to Day 13
Excretion and Recovery of Total Radioactivity and [14C] LY4064809 in Feces
Time frame: Baseline up to Day 13
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 8 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 8 AM - 8 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 LY4064809 and [14C]-LY4064809 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 6 inclusion and 16 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 8 Jun 2026. 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?
To determine the absolute bioavailability (F) of LY4064809 following administration of a single oral dose compared to an intravenous reference dose in healthy participants. (time frame: Baseline up to Day 14). 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 8 Jun 2026.