A Study of Imlunestrant (LY3484356) in Healthy Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Midazolam
* Drug: Imlunestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam + Imlunestrant<br>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. | Drug: Midazolam<br>* Administered orally.<br>Drug: Imlunestrant<br>* Administered orally.<br>* Other names: LY3484356;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam | PK: AUC[0-∞] of Midazolam | Predose up to 48 hours postdose | 
| PK: Maximum Observed Concentration (Cmax) of Midazolam | PK: Cmax of Midazolam | Predose up to 48 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: AUC[0-∞] of 1'-hydroxymidazolam | PK: AUC[0-∞] of 1'-hydroxymidazolam | Predose up to 48 hours postdose | 
| PK: Cmax of 1'-hydroxymidazolam | PK: Cmax of 1'-hydroxymidazolam | Predose up to 48 hours postdose | 
| PK: Area Under the Concentration Versus Time Curve From Zero to 24 hours at steady state (AUC[0-24], ss) of Imlunestrant | PK: AUC[0-24], ss of Imlunestrant | Predose up to 24 hours postdose | 
| PK: Maximum Observed Concentration at steady state (Cmax, ss) of Imlunestrant | PK: Cmax, ss of Imlunestrant | Predose up to 24 hours postdose |