Healthy ParticipantsPhase 1NCT07339735
A Study of LY4064809 in Healthy Adult Participants
A Phase 1 study testing LY4064809 Test Formulation and LY4064809 Reference Formulation in people with Healthy Participants, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- LY4064809 Test Formulation and LY4064809 Reference Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to 19 Mar 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
- Are healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission.
- Have clinical laboratory test results within the normal range
- Have normal blood pressure and pulse rate or not clinically significant
- Have a BMI within the range 18 to 32 kg/m2
- Participants assigned male at birth or assigned female at birth who are not of childbearing potential
Who cannot join
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
- metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
- bile duct disease, including removal of the gall bladder
- digestive system disease
- blood disease
- disease of the nervous system
Show all 15Show fewer
- significant history of, or presence of, liver disease, including any abnormal liver function tests
- heart disease
- Have an abnormal electrocardiogram (ECG) at screening or admission
- History of a major surgical procedure within 30 days prior to screening
- Diagnosed or treated cancer within 5 years prior to screening, with the exception of the following cancers cured through treatment: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ carcinoma of the cervix cured through surgery
- Clinically significant history of multiple or severe drug hypersensitivity reactions or drug allergies, as determined by the investigator
- Have used or plan to use medication within 14 days prior to admission, or plan to use during the study with the exception of acetaminophen
- Have creatinine lab clearance less than 90mL/min calculated using the Cockroft-Gault equation at screening
- Have a positive Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody or human immunodeficiency virus 1 and 2 antibody results at the screening visit
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 to Assess the Relative Bioavailability of Two LY4064809 Formulations in Healthy Adult Participants
The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month.
- Conditions
- Healthy Participants
- Being tested
- LY4064809 Test Formulation, LY4064809 Reference Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4064809 Test FormulationDrug
Also called STX-478
Administered orally
LY4064809 Reference FormulationDrug
Also called STX-478
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4064809 Test | Experimental | LY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods. Receives: Drug: LY4064809 Test Formulation; Drug: LY4064809 Reference Formulation |
| LY4064809 Reference | Experimental | LY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods. Receives: Drug: LY4064809 Test Formulation; Drug: LY4064809 Reference Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
PK: Cmax of LY4064809
Measured: Predose on Day 1 Through Day 28
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
PK: AUC of LY4064809
Measured: Predose on Day 1 Through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start12 Jan 2026
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT07339735
- Sponsor's protocol ID
- 27796
- Other IDs
- J6M-MC-JSGG
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Relative Bioavailability of Two LY4064809 Formulations in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07339735
- Acronym / sponsor ID
- 27796
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 14 Jan 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 find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY4064809 Test | Experimental | Drug: LY4064809 Test Formulation, Drug: LY4064809 Reference FormulationLY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods. |
| LY4064809 Reference | Experimental | Drug: LY4064809 Test Formulation, Drug: LY4064809 Reference FormulationLY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Are healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission.
- Have clinical laboratory test results within the normal range
- Have normal blood pressure and pulse rate or not clinically significant
- Have a BMI within the range 18 to 32 kg/m2
- Participants assigned male at birth or assigned female at birth who are not of childbearing potential
Key exclusion criteria (15 listed)
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
- Have an abnormal electrocardiogram (ECG) at screening or admission
- History of a major surgical procedure within 30 days prior to screening
- Diagnosed or treated cancer within 5 years prior to screening, with the exception of the following cancers cured through treatment: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ carcinoma of the cervix cured through surgery
- Have used or plan to use medication within 14 days prior to admission, or plan to use during the study with the exception of acetaminophen
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 |
|---|---|---|
| LY4064809 Test FormulationAlso: STX-478Administered orally | Drug | LY4064809 Reference, LY4064809 Test |
| LY4064809 Reference FormulationAlso: STX-478Administered orally | Drug | LY4064809 Reference, LY4064809 Test |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
Time frame: Predose on Day 1 Through Day 28
PK: Cmax of LY4064809
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
Time frame: Predose on Day 1 Through Day 28
PK: AUC of LY4064809
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 20 Apr 2026.
- 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 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 Test Formulation and LY4064809 Reference Formulation in people with Healthy Participants, 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 5 inclusion and 15 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 20 Apr 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?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809 (time frame: Predose on Day 1 Through Day 28). 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 20 Apr 2026.