HealthyPhase 1NCT07918859
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
A Phase 1 study testing Imlunestrant (Test), Imlunestrant (Reference) and Omeprazole in people with Healthy, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The main purpose of this study is to measure the amount of imlunestrant that gets into the bloodstream and how long it takes the body to get rid of it when given in two different formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Imlunestrant (Test), Imlunestrant (Reference) and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy
- Have a body mass index (BMI) within the range of 18.0 to 35.0 kilograms per square meter (kg/m²)
Who cannot join
- Have known allergies to imlunestrant (freebase) or or imlunestrant tosylate or omeprazole
- Have significant history or clinical manifestation of an of the following disorders: metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric
- Have a chronic history of liver disease, or known hepatic or biliary abnormalities
- Have a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- Have a clinically significant abnormality of blood pressure or pulse rate
- Have a history of alcoholism or drug/chemical abuse within 2 years prior to starting study
Show all 14Show fewer
- Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
- Have a positive ethanol breath/urine test result or positive urine drug screen
- Show evidence of hepatitis B, positive hepatitis B core antibody, or positive hepatitis B surface antigen
- Have a positive hepatitis C Virus (HCV) antibody test
- Have evidence of Human Immunodeficiency Virus (HIV) infection or positive HIV antibodies
- Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine) per day
- Have received blood products within 2 months prior to check-in on Study Day -1
- Have donated blood within 3 months prior to screening, plasma within 2 weeks prior to screening, or platelets within 6 weeks prior to screening
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
5 sites in 1 country
United States5 sites
ICON
Lenexa, Kansas, 66219
ICON
Salt Lake City, Utah, 84124
ICON Early Phase Services
San Antonio, Texas, 78232
Qps-Mra, Llc
South Miami, Florida, 33143
QPS Missouri
Springfield, Missouri, 65802
About this study
Official title: A Phase 1, Open-Label, 4-Part Study to Investigate the Relative Bioavailability and Bioequivalence of Imlunestrant (LY3484356) Test and Reference Formulations and the Effects of Food and Omeprazole on the Pharmacokinetics of Imlunestrant, in Healthy Female Participants of Non-Childbearing Potential
The main purpose of this study is to measure the amount of imlunestrant that gets into the bloodstream and how long it takes the body to get rid of it when given in two different formulations. This study also compares the two different formulations of imlunestrant against the effects of food and omeprazole in the body.
For each participant, the study may last up to 2.5 months and participants can expect to stay in the clinical research unit (CRU) up to 27 days over several visits.
- Conditions
- Healthy
- Being tested
- Imlunestrant (Test), Imlunestrant (Reference), Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imlunestrant (Test)Drug
Also called LY3484356
Administered orally
Imlunestrant (Reference)Drug
Also called LY3484356
Administered orally
OmeprazoleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Imlunestrant Test Formulation (Part A) | Experimental | Imlunestrant Test Formulation given orally Receives: Drug: Imlunestrant (Test) |
| Imlunestrant Reference Formulation (Part A) | Experimental | Imlunestrant Reference Formulation given orally Receives: Drug: Imlunestrant (Reference) |
| Imlunestrant Test Formulation (Part B) | Experimental | Imlunestrant Test Formulation given orally Receives: Drug: Imlunestrant (Test) |
| Imlunestrant Reference Formulation (Part B) | Experimental | Imlunestrant Reference Formulation given orally Receives: Drug: Imlunestrant (Reference) |
| Imlunestrant Reference Formulation - Fasted State (Part C) | Experimental | Imlunestrant Reference Formulation given orally in fasted state Receives: Drug: Imlunestrant (Reference) |
| Imlunestrant Test Formulation - Fed State (Part C) | Experimental | Imlunestrant Test Formulation 1 or 2 as determined in Part A given orally in fed state. Receives: Drug: Imlunestrant (Test) |
| Imlunestrant Reference and Test Formulation (Part D) | Experimental | Imlunestrant Test Formulation + Omeprazole given orally Receives: Drug: Imlunestrant (Test); Drug: Imlunestrant (Reference); Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Imlunestrant (Freebase)
Measured: Baseline, Up to Day 36
2. PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant (Freebase)
Measured: Baseline, Up to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 343 participants (estimated)
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
- NCT07918859
- Sponsor's protocol ID
- 27814
- Other IDs
- J2J-MC-JZLM
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 4-Part Study to Investigate the Relative Bioavailability and Bioequivalence of Imlunestrant (LY3484356) Test and Reference Formulations and the Effects of Food and Omeprazole on the Pharmacokinetics of Imlunestrant, in Healthy Female Participants of Non-Childbearing Potential
- ClinicalTrials.gov ID
- NCT07918859
- Acronym / sponsor ID
- 27814
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Nov 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 main purpose of this study is to measure the amount of imlunestrant that gets into the bloodstream and how long it takes the body to get rid of it when given in two different formulations. This study also compares the two different formulations of imlunestrant against the effects of food and omeprazole in the body.
For each participant, the study may last up to 2.5 months and participants can expect to stay in the clinical research unit (CRU) up to 27 days over several visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Imlunestrant Test Formulation (Part A) | Experimental | Drug: Imlunestrant (Test)Imlunestrant Test Formulation given orally |
| Imlunestrant Reference Formulation (Part A) | Experimental | Drug: Imlunestrant (Reference)Imlunestrant Reference Formulation given orally |
| Imlunestrant Test Formulation (Part B) | Experimental | Drug: Imlunestrant (Test)Imlunestrant Test Formulation given orally |
| Imlunestrant Reference Formulation (Part B) | Experimental | Drug: Imlunestrant (Reference)Imlunestrant Reference Formulation given orally |
| Imlunestrant Reference Formulation - Fasted State (Part C) | Experimental | Drug: Imlunestrant (Reference)Imlunestrant Reference Formulation given orally in fasted state |
| Imlunestrant Test Formulation - Fed State (Part C) | Experimental | Drug: Imlunestrant (Test)Imlunestrant Test Formulation 1 or 2 as determined in Part A given orally in fed state. |
| Imlunestrant Reference and Test Formulation (Part D) | Experimental | Drug: Imlunestrant (Test), Drug: Imlunestrant (Reference), Drug: OmeprazoleImlunestrant Test Formulation + Omeprazole given orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are overtly healthy
- Have a body mass index (BMI) within the range of 18.0 to 35.0 kilograms per square meter (kg/m²)
Key exclusion criteria (14 listed)
- Have known allergies to imlunestrant (freebase) or or imlunestrant tosylate or omeprazole
- Have significant history or clinical manifestation of an of the following disorders: metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric
- Have a chronic history of liver disease, or known hepatic or biliary abnormalities
- Have a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- Have a clinically significant abnormality of blood pressure or pulse rate
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 |
|---|---|---|
| Imlunestrant (Test)Also: LY3484356Administered orally | Drug | Imlunestrant Reference and Test Formulation (Part D), Imlunestrant Test Formulation (Part A), Imlunestrant Test Formulation (Part B), Imlunestrant Test Formulation - Fed State (Part C) |
| Imlunestrant (Reference)Also: LY3484356Administered orally | Drug | Imlunestrant Reference Formulation (Part A), Imlunestrant Reference Formulation (Part B), Imlunestrant Reference Formulation - Fasted State (Part C), Imlunestrant Reference and Test Formulation (Part D) |
| OmeprazoleAdministered orally | Drug | Imlunestrant Reference and Test Formulation (Part D) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Imlunestrant (Freebase)
Time frame: Baseline, Up to Day 36
2. PK: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant (Freebase)
Time frame: Baseline, Up to Day 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imlunestrant (Test), Imlunestrant (Reference) and Omeprazole in people with Healthy, run by Eli Lilly and Company at 5 sites 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 2 inclusion and 14 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Imlunestrant (Freebase) (time frame: Baseline, Up to Day 36). 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 Nov 2026.