HealthyPhase 1NCT06991179
A Study of Food Effect and Esomeprazole on LY4064809 in Healthy Adult Participants
A Phase 1 study testing LY4064809 in people with Healthy, run by Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton pump inhibitor (PPI) esomeprazole, under fasted conditions in healthy adult participants. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2025to 2 Sep 2025
- 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 no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee)
- Participants have normal blood pressure and pulse rate, as determined by the investigator
- Have venous access sufficient to allow for blood sampling
- Have a body mass index (BMI) within the range 18-32 kilogram/square meter (kg/m²) (inclusive)
- Individuals not of childbearing potential and individuals assigned male at birth may participate in this trial
Who cannot join
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention or interfere with the data interpretation:
- Metabolic disease, including congenital non-hemolytic hyperbilirubinemia (for example, Gilbert syndrome),
- Biliary disease, including cholecystectomy,
- Gastrointestinal (GI) disease,
- Hematological disease,
- Neurological disease,
Show all 12Show fewer
- Significant history of, or presence of hepatic disease, including any abnormal liver function tests and serum total bilirubin above the 1.5
- × upper limits of normal (ULN) range per the laboratory's reference ranges at screening or admission, or
- Clinically significant, active cardiovascular disease or history of myocardial infarction within 6 months prior to the planned start of LY4064809
- History of a major surgical procedure within 30 days prior to screening
- Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix.
- Have known allergies to LY4064809 or related compounds or esomeprazole or related compounds
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center Inc
Baltimore, Maryland, 21201
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Effects of Food and Multiple-Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose of LY4064809 in Healthy Adult Participants
The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton pump inhibitor (PPI) esomeprazole, under fasted conditions in healthy adult participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
- Conditions
- Healthy
- Being tested
- LY4064809
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4064809Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Treatment A Fasted | Experimental | LY4064809 administered orally Receives: Drug: LY4064809 |
| Group 1 Treatment B High-Fat Meal | Experimental | LY4064809 administered orally Receives: Drug: LY4064809 |
| Group 2 Treatment A Fasted | Experimental | LY4064809 administered orally Receives: Drug: LY4064809 |
| Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect | Experimental | LY4064809 administered orally with esomeprazole Receives: Drug: LY4064809 |
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: Day 1 to Approximately Day 47
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time T (AUC 0-tlast)
PK: AUC 0-tlast, where t is the last time point with a measurable concentration
Measured: Day 1 to Approximately Day 47
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Zero to Infinity (AUCinf)
PK: AUCinf
Measured: Day 1 to Approximately Day 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2025
- Study start20 May 2025
- Primary completion2 Sep 2025
- Study completion2 Sep 2025
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.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
- NCT06991179
- Sponsor's protocol ID
- 27693
- Other IDs
- J6M-MC-JSGC
- Status last verified
- Sep 2025
- First submitted
- 19 May 2025
- Last updated
- 23 Sep 2025
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Effects of Food and Multiple-Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose of LY4064809 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06991179
- Acronym / sponsor ID
- 27693
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 26 May 2025 (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 evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton pump inhibitor (PPI) esomeprazole, under fasted conditions in healthy adult participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Treatment A Fasted | Experimental | Drug: LY4064809LY4064809 administered orally |
| Group 1 Treatment B High-Fat Meal | Experimental | Drug: LY4064809LY4064809 administered orally |
| Group 2 Treatment A Fasted | Experimental | Drug: LY4064809LY4064809 administered orally |
| Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect | Experimental | Drug: LY4064809LY4064809 administered orally with esomeprazole |
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 no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee)
- Participants have normal blood pressure and pulse rate, as determined by the investigator
- Have venous access sufficient to allow for blood sampling
- Have a body mass index (BMI) within the range 18-32 kilogram/square meter (kg/m²) (inclusive)
- Individuals not of childbearing potential and individuals assigned male at birth may participate in this trial
Key exclusion criteria (12 listed)
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention or interfere with the data interpretation:
- × upper limits of normal (ULN) range per the laboratory's reference ranges at screening or admission, or
- History of a major surgical procedure within 30 days prior to screening
- Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix.
- Have known allergies to LY4064809 or related compounds or esomeprazole 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 | Group 1 Treatment A Fasted, Group 1 Treatment B High-Fat Meal, Group 2 Treatment A Fasted, Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
Time frame: Day 1 to Approximately Day 47
PK: Cmax of LY4064809
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Time T (AUC 0-tlast)
Time frame: Day 1 to Approximately Day 47
PK: AUC 0-tlast, where t is the last time point with a measurable concentration
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Zero to Infinity (AUCinf)
Time frame: Day 1 to Approximately Day 47
PK: AUCinf
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 23 Sep 2025.
- 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.
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 LY4064809 in people with Healthy, run by Scorpion Therapeutics, a wholly owned subsidiary of 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 12 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 23 Sep 2025. 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: Day 1 to Approximately Day 47). 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?
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 23 Sep 2025.