HealthyPhase 1NCT05444556

A Study of Imlunestrant (LY3484356) in Female Healthy Participants

A Phase 1 study testing Imlunestrant, Repaglinide and Omeprazole in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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, Repaglinide and Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 3 sitesUnited States
Study dates: 7 Jul 2022to 2 Nov 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participants who are overtly healthy as determined by medical assessment
Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
Female participants of non childbearing potential.

Who cannot join

Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
ICON Early Phase Services
San Antonio, Texas, 78209
Qps-Mra, Llc
South Miami, Florida, 33143-4875

Other trials in United States

About this study

Official title: The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential

The main purpose of this study is to evaluate the effect of imlunestrant on repaglinide, omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also investigate the effect of quinidine on imlunestrant in female healthy participants of non-childbearing potential. The safety and tolerability of imlunestrant will be investigated in female healthy participants of non-childbearing potential. The study will last approximately up to 32 days for each participant excluding the screening period.

Conditions: Healthy
Being tested: Imlunestrant, Repaglinide, Omeprazole, Dextromethorphan, Quinidine

What participants receive

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

ImlunestrantDrug
Also called LY3484356
Administered orally.
RepaglinideDrug
Administered orally.
OmeprazoleDrug
Administered orally.
DextromethorphanDrug
Administered orally.
QuinidineDrug
Administered orally.
RosuvastatinDrug
Administered orally.
DigoxinDrug
Administered orally.

Study groups in NCT05444556
Study group	Role	What they receive
Imlunestrant + Repaglinide (Cohort 1)	Experimental	Participants received: Day 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally. Receives: Drug: Imlunestrant; Drug: Repaglinide
mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)	Experimental	Participants received: Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning. Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally. Receives: Drug: Imlunestrant; Drug: Omeprazole; Drug: Dextromethorphan
Imlunestrant + Quinidine (Cohort 3)	Experimental	Participants received: Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone. Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen). Receives: Drug: Imlunestrant; Drug: Quinidine
Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)	Experimental	Participants received: Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning. Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally. Receives: Drug: Imlunestrant; Drug: Rosuvastatin; Drug: Digoxin

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)
PK: AUC[0-∞] of Repaglinide
Measured: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)
PK: Cmax of Repaglinide
Measured: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
PK: AUC[0-∞] of Omeprazole (Cohort 2)
PK: AUC[0-∞] of Omeprazole
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Cmax of Omeprazole (Cohort 2)
PK: Cmax of Omeprazole
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)
5-hydroxyomeprazole is a major metabolite of omeprazole.
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)
5-hydroxyomeprazole is a major metabolite of omeprazole.
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: AUC[0-∞] of Dextromethorphan (Cohort 2)
PK: AUC[0-∞] of Dextromethorphan
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Cmax of Dextromethorphan (Cohort 2)
PK: Cmax of Dextromethorphan
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)
Dextrorphan is a major metabolite of Dextromethorphan.
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)
Dextrorphan is a major metabolite of Dextromethorphan.
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: AUC[0-∞] of Imlunestrant (Cohort 3)
PK: AUC[0-∞] of Imlunestrant
Measured: Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose
PK: Cmax of Imlunestrant (Cohort 3)
PK: Cmax of Imlunestrant
Measured: Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose
PK: AUC[0-∞] of Rosuvastatin (Cohort 4)
PK: AUC[0-∞] of Rosuvastatin
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: Cmax of Rosuvastatin (Cohort 4)
PK: Cmax of Rosuvastatin
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: AUC[0-∞] of Digoxin (Cohort 4)
PK: AUC[0-∞] of Digoxin
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: Cmax of Digoxin (Cohort 4)
PK: Cmax of Digoxin
Measured: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose

Timeline

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

7 Jul 20222 Nov 2022

First posted6 Jul 2022
Study start7 Jul 2022
Primary completion2 Nov 2022
Study completion2 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05444556
Sponsor's protocol ID: 18413
Other IDs: J2J-MC-JZLI
Status last verified: 15 Nov 2025
First submitted: 30 Jun 2022
Last updated: 12 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential
ClinicalTrials.gov ID: NCT05444556
Acronym / sponsor ID: 18413
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 7 Jul 2022 (actual)
Primary completion: 2 Nov 2022 (actual)
Study completion: 2 Nov 2022 (actual)
First posted: 6 Jul 2022 (actual)
Results: Posted 12 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Imlunestrant + Repaglinide (Cohort 1)	Experimental	Drug: Imlunestrant, Drug: RepaglinideParticipants received: Day 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.
mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)	Experimental	Drug: Imlunestrant, Drug: Omeprazole, Drug: DextromethorphanParticipants received: Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning. Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.
Imlunestrant + Quinidine (Cohort 3)	Experimental	Drug: Imlunestrant, Drug: QuinidineParticipants received: Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone. Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).
Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)	Experimental	Drug: Imlunestrant, Drug: Rosuvastatin, Drug: DigoxinParticipants received: Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning. Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants who are overtly healthy as determined by medical assessment
Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
Female participants of non childbearing potential.

Key exclusion criteria (4 listed)

Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).

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
ImlunestrantAlso: LY3484356Administered orally.	Drug	Imlunestrant + Quinidine (Cohort 3), Imlunestrant + Repaglinide (Cohort 1), Imlunestrant + Rosuvastatin & Digoxin (Cohort 4), mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)
RepaglinideAdministered orally.	Drug	Imlunestrant + Repaglinide (Cohort 1)
OmeprazoleAdministered orally.	Drug	mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)
DextromethorphanAdministered orally.	Drug	mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)
QuinidineAdministered orally.	Drug	Imlunestrant + Quinidine (Cohort 3)
RosuvastatinAdministered orally.	Drug	Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)
DigoxinAdministered orally.	Drug	Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)
Time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
PK: AUC[0-∞] of Repaglinide
PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)
Time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
PK: Cmax of Repaglinide
PK: AUC[0-∞] of Omeprazole (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: AUC[0-∞] of Omeprazole
PK: Cmax of Omeprazole (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Cmax of Omeprazole
PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
5-hydroxyomeprazole is a major metabolite of omeprazole.
PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
5-hydroxyomeprazole is a major metabolite of omeprazole.
PK: AUC[0-∞] of Dextromethorphan (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: AUC[0-∞] of Dextromethorphan
PK: Cmax of Dextromethorphan (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
PK: Cmax of Dextromethorphan
PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
Dextrorphan is a major metabolite of Dextromethorphan.
PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose
Dextrorphan is a major metabolite of Dextromethorphan.
PK: AUC[0-∞] of Imlunestrant (Cohort 3)
Time frame: Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose
PK: AUC[0-∞] of Imlunestrant
PK: Cmax of Imlunestrant (Cohort 3)
Time frame: Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose
PK: Cmax of Imlunestrant
PK: AUC[0-∞] of Rosuvastatin (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: AUC[0-∞] of Rosuvastatin
PK: Cmax of Rosuvastatin (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: Cmax of Rosuvastatin
PK: AUC[0-∞] of Digoxin (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: AUC[0-∞] of Digoxin
PK: Cmax of Digoxin (Cohort 4)
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose
PK: Cmax of Digoxin

Results and safety

Results posted to the registry on 12 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imlunestrant + Repaglinide (Cohort 1)	27	27
Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2)	27	27
Imlunestrant + Quinidine (Cohort 3)	32	30
Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)	27	26

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)

Time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	0.5 mg Repaglinide n = 24	800 mg Imlunestrant + 0.5 mg Repaglinide n = 23
Value	13.0 (31)	13.6 (31)

Population analysed: All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome.

Primary outcome: PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)

Time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per millilitre (ng/mL)

Measure	0.5 mg Repaglinide n = 27	800 mg Imlunestrant + 0.5 mg Repaglinide n = 27
Value	10.5 (38)	9.84 (44)

Population analysed: All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome.

Primary outcome: PK: AUC[0-∞] of Omeprazole (Cohort 2)

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	20 mg Omeprazole + 30 mg Dextromethorphan n = 21	800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan n = 26
Value	703 (77)	825 (74)

Population analysed: All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.

Primary outcome: PK: Cmax of Omeprazole (Cohort 2)

Measure	20 mg Omeprazole + 30 mg Dextromethorphan n = 27	800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan n = 27
Value	316 (73)	405 (57)

Population analysed: All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome.

Adverse events

Time frame: Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.5 mg Repaglinide: Cohort 1	0 of 27 (0%)	2 of 27 (7.4%)	0 of 27
800 mg Imlunestrant + 0.5 mg Repaglinide: Cohort 1	0 of 27 (0%)	0 of 27 (0%)	0 of 27
20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2	0 of 27 (0%)	3 of 27 (11.1%)	0 of 27
800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2	0 of 27 (0%)	3 of 27 (11.1%)	0 of 27
400 mg Imlunestrant (Day 1): Cohort 3	0 of 32 (0%)	9 of 32 (28.1%)	0 of 32
200 mg Quinidine BID (Days 15 to 17): Cohort 3	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
400 mg Imlunestrant + 200 mg Quinidine BID (Day 18): Cohort 3	0 of 31 (0%)	0 of 31 (0%)	0 of 31
200 mg Quinidine BID (Days 19 to 24): Cohort 3	0 of 31 (0%)	4 of 31 (12.9%)	0 of 31
10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4	0 of 27 (0%)	0 of 27 (0%)	0 of 27
400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4	0 of 26 (0%)	1 of 26 (3.8%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

3 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, Repaglinide and Omeprazole in people with Healthy, run by Eli Lilly and Company at 3 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 3 inclusion and 4 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1) (time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose). The study lists 16 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 NCT05444556.

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 12 Dec 2025.