Midazolam + Imlunestrant for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Labcorp Clinical Research Unit Inc., Dallas, TX
Healthy Subjects (HS)
Midazolam - Drug
Eligibility
18+
Female
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Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Predose up to 48 hours postdose

Hour 24
PK: Area Under the Concentration Versus Time Curve From Zero to 24 hours at steady state (AUC[0-24], ss) of Imlunestrant
PK: Maximum Observed Concentration at steady state (Cmax, ss) of Imlunestrant
Hour 48
PK: AUC[0-∞] of 1'-hydroxymidazolam
PK: Cmax of 1'-hydroxymidazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Midazolam + Imlunestrant
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Midazolam + Imlunestrant · No Placebo Group · Phase 1

Midazolam + ImlunestrantExperimental Group · 2 Interventions: Midazolam, Imlunestrant · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1920

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 48 hours postdose
Closest Location: Labcorp Clinical Research Unit Inc. · Dallas, TX
Photo of Dallas  1Photo of Dallas  2Photo of Dallas  3
2021First Recorded Clinical Trial
4 TrialsResearching Healthy Subjects (HS)
3 CompletedClinical Trials

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.