HealthyPhase 1NCT05509816

A Study of Imlunestrant (LY3484356) in Healthy Women

A Phase 1 study testing Midazolam and Imlunestrant in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.

Completed

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

Official record

Search all trials

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?: Midazolam and Imlunestrant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 12 Sep 2022to 30 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

Women not of childbearing potential
Participants who are overtly healthy as determined by medical assessment
Participants with body mass index (BMI) of 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive

Who cannot join

Have known allergies to imlunestrant, related compounds or any components of the formulation or midazolam
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
Use or intend to use medications that are substrate drugs of P-glycoprotein

Trial locations and contacts

2 sites in 1 country.

United States2 sites

LabCorp CRU, Inc.
Dallas, Texas, 75247
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: The Effect of Repeat Dosing of Imlunestrant on CYP3A Activity in Healthy Women of Non-childbearing Potential

The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of non-childbearing potential. This study will last up to approximately 6 weeks for each participant including the screening period.

Conditions: Healthy
Being tested: Midazolam, Imlunestrant

What participants receive

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

MidazolamDrug
Administered orally.
ImlunestrantDrug
Also called LY3484356
Administered orally.

Study groups in NCT05509816
Study group	Role	What they receive
Midazolam + Imlunestrant	Experimental	Participants received 400 milligram (mg) Imlunestrant (2 × 200 mg) tablets administered once daily (QD) orally for 7 days on Days 3 to 9 and a single dose of 0.5 mg midazolam solution orally on Day 1 and Day 9 as per below dosing sequence: Day 1: 0.5 mg midazolam alone Days 3 to 8: 400 mg imlunestrant QD alone Day 9: 0.5 mg midazolam + 400 mg imlunestrant There was a washout period of 8 days between doses of midazolam. Receives: Drug: Midazolam; Drug: Imlunestrant

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 Midazolam
PK: AUC[0-∞] of Midazolam
Measured: Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: Maximum Observed Concentration (Cmax) of Midazolam
PK: Cmax of Midazolam
Measured: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose

Secondary outcomes (4)

PK: AUC[0-∞] of 1'-Hydroxymidazolam
PK: AUC[0-∞] of 1'-hydroxymidazolam
Measured: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: Cmax of 1'-Hydroxymidazolam
PK: Cmax of 1'-hydroxymidazolam
Measured: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: Area Under the Concentration Versus Time Curve From Zero to 24 Hours at Steady State (AUC[0-24], ss) of Imlunestrant When Dosed in the Presence of Midazolam
PK: AUC[0-24], ss of Imlunestrant
Measured: Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose
PK: Maximum Observed Concentration at Steady State (Cmax, ss) of Imlunestrant When Dosed in the Presence of Midazolam
PK: Cmax, ss of Imlunestrant when dosed in the presence of Midazolam is evaluated.
Measured: Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose

Timeline

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

12 Sep 202230 Nov 2022

First posted22 Aug 2022
Study start12 Sep 2022
Primary completion30 Nov 2022
Study completion30 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: Not applicable
Intervention model: Crossover
Model description: This is a fixed sequence, crossover study
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05509816
Sponsor's protocol ID: 18416
Other IDs: J2J-MC-JZLK
Status last verified: Oct 2025
First submitted: 19 Aug 2022
Last updated: 12 Nov 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?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

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

Official title: The Effect of Repeat Dosing of Imlunestrant on CYP3A Activity in Healthy Women of Non-childbearing Potential
ClinicalTrials.gov ID: NCT05509816
Acronym / sponsor ID: 18416
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 12 Sep 2022 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 22 Aug 2022 (actual)
Results: Posted 12 Nov 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: Not applicable
Intervention model: Crossover
Masking: None (open label)
Number of arms: 1
Model description: This is a fixed sequence, crossover study

Arm	Type	Receives
Midazolam + Imlunestrant	Experimental	Drug: Midazolam, Drug: ImlunestrantParticipants received 400 milligram (mg) Imlunestrant (2 × 200 mg) tablets administered once daily (QD) orally for 7 days on Days 3 to 9 and a single dose of 0.5 mg midazolam solution orally on Day 1 and Day 9 as per below dosing sequence: Day 1: 0.5 mg midazolam alone Days 3 to 8: 400 mg imlunestrant QD alone Day 9: 0.5 mg midazolam + 400 mg imlunestrant There was a washout period of 8 days between doses of midazolam.

Who may qualify

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

Key inclusion criteria (3 listed)

Women not of childbearing potential
Participants who are overtly healthy as determined by medical assessment
Participants with body mass index (BMI) of 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive

Key exclusion criteria (3 listed)

Have known allergies to imlunestrant, related compounds or any components of the formulation or midazolam
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
Use or intend to use medications that are substrate drugs of P-glycoprotein

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
MidazolamAdministered orally.	Drug	Midazolam + Imlunestrant
ImlunestrantAlso: LY3484356Administered orally.	Drug	Midazolam + Imlunestrant

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Time frame: Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: AUC[0-∞] of Midazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam
Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: Cmax of Midazolam

4 secondary outcomes

PK: AUC[0-∞] of 1'-Hydroxymidazolam
Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: Cmax of 1'-Hydroxymidazolam
Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose
PK: Area Under the Concentration Versus Time Curve From Zero to 24 Hours at Steady State (AUC[0-24], ss) of Imlunestrant When Dosed in the Presence of Midazolam
Time frame: Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose
PK: Maximum Observed Concentration at Steady State (Cmax, ss) of Imlunestrant When Dosed in the Presence of Midazolam
Time frame: Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose

Results and safety

Results posted to the registry on 12 Nov 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
Midazolam + Imlunestrant	20	19

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

Time frame: Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	0.5 mg Midazolam n = 20	0.5 mg Midazolam + 400 mg Imlunestrant n = 20
Value	12.3 (32)	11.4 (41)

0.5 mg Midazolam vs 0.5 mg Midazolam + 400 mg Imlunestrant: Ratio of Geometric least squares mean: 0.929 (90% CI 0.849 to 1.02), Mixed Models Analysis

Population analysed: All participants who received at least one dose of study drug (midazolam) and had evaluable PK data.

Primary outcome: PK: Maximum Observed Concentration (Cmax) of Midazolam

Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	0.5 mg Midazolam n = 20	0.5 mg Midazolam + 400 mg Imlunestrant n = 20
Value	3.84 (35)	4.12 (31)

0.5 mg Midazolam vs 0.5 mg Midazolam + 400 mg Imlunestrant: Ratio of Geometric least squares mean: 1.07 (90% CI 0.989 to 1.16), Mixed Models Analysis

Population analysed: All participants who received at least one dose of study drug (midazolam) and had evaluable PK data.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up to Day 18. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.5 mg Midazolam	0 of 20 (0%)	0 of 20 (0%)	0 of 20
400 mg Imlunestrant	0 of 20 (0%)	5 of 20 (25%)	0 of 20
0.5 mg Midazolam + 400 mg Imlunestrant	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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

2 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 Midazolam and Imlunestrant in people with Healthy, run by Eli Lilly and Company at 2 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 3 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Nov 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 Midazolam (time frame: Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose). 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?

On the ClinicalTrials.gov record for NCT05509816.

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 Nov 2025.