A Study of Imlunestrant (LY3484356) in Healthy Women

Eli Lilly and Company20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MidazolamDRUG

Administered orally.

ImlunestrantDRUG

Administered orally.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

LabCorp CRU, Inc.

Daytona Beach, Florida, United States

LabCorp CRU, Inc.

Dallas, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam

PK: AUC\[0-∞\] of Midazolam

Time frame: Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose

PK: Maximum Observed Concentration (Cmax) of Midazolam

PK: Cmax of Midazolam

Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose

Secondary Outcomes

PK: AUC[0-∞] of 1'-Hydroxymidazolam

PK: AUC\[0-∞\] of 1'-hydroxymidazolam

Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose

PK: Cmax of 1'-Hydroxymidazolam

PK: Cmax of 1'-hydroxymidazolam

Time frame: Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose

PK: Area Under the Concentration Versus Time Curve From Zero to 24 Hours at Steady State (AUC[0-24], ss) of Imlunestrant When Dosed in the Presence of Midazolam

PK: AUC\[0-24\], ss of Imlunestrant

Time frame: Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose

PK: Maximum Observed Concentration at Steady State (Cmax, ss) of Imlunestrant When Dosed in the Presence of Midazolam

PK: Cmax, ss of Imlunestrant when dosed in the presence of Midazolam is evaluated.

Data from ClinicalTrials.gov

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