Imlunestrant for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ICON Early Phase Services, San Antonio, TX
Healthy Subjects (HS)
Imlunestrant - Drug
Eligibility
18+
Female
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Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

16 Primary · 0 Secondary · Reporting Duration: Predose up to 168 hours postdose

Hour 120
PK: AUC[0-∞] of Digoxin
PK: AUC[0-∞] of Rosuvastatin
PK: Cmax of Digoxin
PK: Cmax of Rosuvastatin
Hour 168
PK: AUC[0-∞] of Imlunestrant
PK: Cmax of Imlunestrant
Hour 24
PK: Maximum Observed Concentration (Cmax) of Repaglinide
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide
Hour 48
PK: AUC[0-∞] of 5-hydroxyomeprazole
PK: AUC[0-∞] of Dextromethorphan
PK: AUC[0-∞] of Dextrorphan
PK: AUC[0-∞] of Omeprazole
PK: Cmax of 5-hydroxyomeprazole
PK: Cmax of Dextromethorphan
PK: Cmax of Dextrorphan
PK: Cmax of Omeprazole

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

4 Treatment Groups

Imlunestrant + Omeprazole & Dextromethorphan
1 of 4
Imlunestrant + Quinidine
1 of 4
Imlunestrant + Repaglinide
1 of 4
Imlunestrant + Rosuvastatin & Digoxin
1 of 4
Experimental Treatment

113 Total Participants · 4 Treatment Groups

Primary Treatment: Imlunestrant · No Placebo Group · Phase 1

Imlunestrant + Omeprazole & DextromethorphanExperimental Group · 3 Interventions: Dextromethorphan, Omeprazole, Imlunestrant · Intervention Types: Drug, Drug, Drug
Imlunestrant + QuinidineExperimental Group · 2 Interventions: Quinidine, Imlunestrant · Intervention Types: Drug, Drug
Imlunestrant + RepaglinideExperimental Group · 2 Interventions: Repaglinide, Imlunestrant · Intervention Types: Drug, Drug
Imlunestrant + Rosuvastatin & DigoxinExperimental Group · 3 Interventions: Rosuvastatin, Imlunestrant, Digoxin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quinidine
2012
Completed Phase 1
~460
Rosuvastatin
2019
Completed Phase 4
~3150
Repaglinide
2016
Completed Phase 4
~6720
Dextromethorphan
2019
Completed Phase 4
~920
Omeprazole
2006
Completed Phase 4
~940
Digoxin
2017
Completed Phase 4
~670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: predose up to 168 hours postdose
Closest Location: ICON Early Phase Services · San Antonio, TX
Photo of San Antonio 1Photo of San Antonio 2Photo of San Antonio 3
2016First Recorded Clinical Trial
10 TrialsResearching Healthy Subjects (HS)
15 CompletedClinical Trials

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,428 Previous Clinical Trials
3,118,131 Total Patients Enrolled
313 Trials studying Healthy Subjects (HS)
15,710 Patients Enrolled for Healthy Subjects (HS)
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 DirectorEli Lilly and Company
1,231 Previous Clinical Trials
364,746 Total Patients Enrolled
272 Trials studying Healthy Subjects (HS)
13,258 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.