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Selective Estrogen Receptor Degrader

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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 168 hours postdose
Awards & highlights

Study Summary

This trial is testing a new drug, Imlunestrant, to see what effect it has on other drugs' effectiveness and safety. It will also study Imlunestrant's effect on healthy female participants who can't have children. The trial will last about 32 days for each person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 168 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 168 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: AUC[0-∞] of 5-hydroxyomeprazole
PK: AUC[0-∞] of Dextromethorphan
Dextrorphan
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Imlunestrant + Rosuvastatin & DigoxinExperimental Treatment3 Interventions
Rosuvastatin administered in combination with digoxin administered orally on day 1 followed by imlunestrant administered orally in combination with rosuvastatin and digoxin orally on day 10.
Group II: Imlunestrant + RepaglinideExperimental Treatment2 Interventions
Repaglinide administered orally alone on day 1 followed by imlunestrant administered orally in combination with repaglinide orally on day 3.
Group III: Imlunestrant + QuinidineExperimental Treatment2 Interventions
Imlunestrant administered orally on day 1 followed by quinidine alone orally on day 15 to 17. On day 18, imlunestrant administered orally in combination with quinidine followed by quinidine administered orally on day 19 to 24.
Group IV: Imlunestrant + Omeprazole & DextromethorphanExperimental Treatment3 Interventions
Omeprazole administered in combination with dextromethorphan orally on day 1 followed by imlunestrant administered orally in combination with omeprazole and dextromethorphan orally on day 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digoxin
2017
Completed Phase 4
~670
Imlunestrant
2022
Completed Phase 1
~140
Repaglinide
2016
Completed Phase 4
~7040
Omeprazole
2006
Completed Phase 4
~940
Dextromethorphan
2019
Completed Phase 4
~920
Quinidine
2012
Completed Phase 1
~610
Rosuvastatin
2019
Completed Phase 4
~3150

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
2,605 Previous Clinical Trials
3,199,557 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,732 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
California
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Qps-Mra, Llc
Altasciences Clinical Los Angeles, Inc
ICON Early Phase Services
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~42 spots leftby Mar 2025