← Back to Search

Selective Estrogen Receptor Degrader (SERD)

Imlunestrant for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 48 hours postdose
Awards & highlights

Study Summary

This trial will study the effects of a new drug, imlunestrant, on the levels of midazolam in the blood stream of healthy women who cannot have children. The trial will also study the safety of the new drug. The study will last up to 6 weeks for each participant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 48 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 48 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Maximum Observed Concentration (Cmax) of Midazolam
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Secondary outcome measures
PK: AUC[0-∞] of 1'-hydroxymidazolam
PK: Area Under the Concentration Versus Time Curve From Zero to 24 hours at steady state (AUC[0-24], ss) of Imlunestrant
PK: Cmax of 1'-hydroxymidazolam
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Midazolam + ImlunestrantExperimental Treatment2 Interventions
Midazolam administered orally alone on day 1 followed by imlunestrant administered orally alone on days 3 to 8. On day 9, midazolam is administered orally in combination with imlunestrant orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
Imlunestrant
2022
Completed Phase 1
~170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,617 Previous Clinical Trials
3,201,180 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,346 Previous Clinical Trials
405,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Imlunestrant (LY3484356) in Healthy Women
2022. "A Study of Imlunestrant (LY3484356) in Healthy Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05509816.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top