NCT05509816

A Study of Imlunestrant (LY3484356) in Healthy Women

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Midazolam	Administered orally.
DRUG	Imlunestrant	Administered orally.

Timeline

• Start date: 2022-09-12
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-08-22
• Last updated: 2025-11-12
• Results posted: 2025-11-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study