Overview

A Study of Imlunestrant (LY3484356) in Healthy Women

Status:
Not yet recruiting
Trial end date:
2022-11-08
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Midazolam
Criteria
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