A Study of Imlunestrant (LY3484356) in Healthy Women

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Imlunestrant; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509816

J2J-MC-JZLK (Other Identifier)

18416

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Midazolam + Imlunestrant

Experimental group

Description:

Participants received 400 milligram (mg) Imlunestrant (2 × 200 mg) tablets administered once daily (QD) orally for 7 days on Days 3 to 9 and a single dose of 0.5 mg midazolam solution orally on Day 1 and Day 9 as per below dosing sequence: Day 1: 0.5 mg midazolam alone Days 3 to 8: 400 mg imlunestrant QD alone Day 9: 0.5 mg midazolam + 400 mg imlunestrant There was a washout period of 8 days between doses of midazolam.

Treatment:

Drug: Midazolam

Drug: Imlunestrant