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

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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