A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Healthy Clinical Trial

Official title:

The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444556
• Other study ID #: 18413
• Secondary ID: J2J-MC-JZLI
• Status: Completed
• Phase: Phase 1
• Start date: July 7, 2022
• Est. completion date: November 2, 2022

Study information

• Verified date: November 15, 2022
• 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 on repaglinide, omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also investigate the effect of quinidine on imlunestrant in female healthy participants of non-childbearing potential. The safety and tolerability of imlunestrant will be investigated in female healthy participants of non-childbearing potential. The study will last approximately up to 32 days for each participant excluding the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical assessment

• Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)

• Female participants of non childbearing potential.

Exclusion Criteria:

• Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator

• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing

• Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Imlunestrant
Administered orally.
• Repaglinide
Administered orally.
• Omeprazole
Administered orally.
• Dextromethorphan
Administered orally.
• Quinidine
Administered orally.
• Rosuvastatin
Administered orally.
• Digoxin
Administered orally.

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California
United States	ICON Early Phase Services	San Antonio	Texas
United States	Qps-Mra, Llc	South Miami	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 Repaglinide	PK: AUC[0-8] of Repaglinide	Predose up to 24 hours postdose
Primary	PK: Maximum Observed Concentration (Cmax) of Repaglinide	PK: Cmax of Repaglinide	Predose up to 24 hours postdose
Primary	PK: AUC[0-8] of Omeprazole	PK: AUC[0-8] of Omeprazole	Predose up to 48 hours postdose
Primary	PK: Cmax of Omeprazole	PK: Cmax of Omeprazole	Predose up to 48 hours postdose
Primary	PK: AUC[0-8] of 5-hydroxyomeprazole	PK: AUC[0-8] of 5-hydroxyomeprazole	Predose up to 48 hours postdose
Primary	PK: Cmax of 5-hydroxyomeprazole	PK: Cmax of 5-hydroxyomeprazole	Predose up to 48 hours postdose
Primary	PK: AUC[0-8] of Dextromethorphan	PK: AUC[0-8] of Dextromethorphan	Predose up to 48 hours postdose
Primary	PK: Cmax of Dextromethorphan	PK: Cmax of Dextromethorphan	Predose up to 48 hours postdose
Primary	PK: AUC[0-8] of Dextrorphan	PK: AUC[0-8] of Dextrorphan	Predose up to 48 hours postdose
Primary	PK: Cmax of Dextrorphan	PK: Cmax of Dextrorphan	Predose up to 48 hours postdose
Primary	PK: AUC[0-8] of Imlunestrant	PK: AUC[0-8] of Imlunestrant	Predose up to 168 hours postdose
Primary	PK: Cmax of Imlunestrant	PK: Cmax of Imlunestrant	Predose up to 168 hours postdose
Primary	PK: AUC[0-8] of Rosuvastatin	PK: AUC[0-8] of Rosuvastatin	Predose up to 120 hours postdose
Primary	PK: Cmax of Rosuvastatin	PK: Cmax of Rosuvastatin	Predose up to 120 hours postdose
Primary	PK: AUC[0-8] of Digoxin	PK: AUC[0-8] of Digoxin	Predose up to 120 hours postdose
Primary	PK: Cmax of Digoxin	PK: Cmax of Digoxin	Predose up to 120 hours postdose