A Study of Imlunestrant (LY3484356) in Healthy Women

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509816
• Other study ID #: 18416
• Secondary ID: J2J-MC-JZLK
• Status: Completed
• Phase: Phase 1
• Start date: September 12, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Midazolam
Administered orally.
• Imlunestrant
Administered orally.

Locations

Country	Name	City	State
United States	LabCorp CRU, Inc.	Dallas	Texas
United States	LabCorp CRU, Inc.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Midazolam	PK: AUC[0-8] of Midazolam	Predose up to 48 hours postdose
Primary	PK: Maximum Observed Concentration (Cmax) of Midazolam	PK: Cmax of Midazolam	Predose up to 48 hours postdose
Secondary	PK: AUC[0-8] of 1'-hydroxymidazolam	PK: AUC[0-8] of 1'-hydroxymidazolam	Predose up to 48 hours postdose
Secondary	PK: Cmax of 1'-hydroxymidazolam	PK: Cmax of 1'-hydroxymidazolam	Predose up to 48 hours postdose
Secondary	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
Secondary	PK: Maximum Observed Concentration at steady state (Cmax, ss) of Imlunestrant	PK: Cmax, ss of Imlunestrant	Predose up to 24 hours postdose