A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05444556

Collaborator

(none)

113

Enrollment

Locations

Arms

3.8

Anticipated Duration (Months)

37.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Imlunestrant Drug: Repaglinide Drug: Omeprazole Drug: Dextromethorphan Drug: Quinidine Drug: Rosuvastatin Drug: Digoxin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jul 7, 2022

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Imlunestrant + Repaglinide Repaglinide administered orally alone on day 1 followed by imlunestrant administered orally in combination with repaglinide orally on day 3.	Drug: Imlunestrant Administered orally. Other Names: LY3484356 Drug: Repaglinide Administered orally.
Experimental: Imlunestrant + Omeprazole & Dextromethorphan Omeprazole administered in combination with dextromethorphan orally on day 1 followed by imlunestrant administered orally in combination with omeprazole and dextromethorphan orally on day 3.	Drug: Imlunestrant Administered orally. Other Names: LY3484356 Drug: Omeprazole Administered orally. Drug: Dextromethorphan Administered orally.
Experimental: Imlunestrant + Quinidine Imlunestrant administered orally on day 1 followed by quinidine alone orally on day 15 to 17. On day 18, imlunestrant administered orally in combination with quinidine followed by quinidine administered orally on day 19 to 24.	Drug: Imlunestrant Administered orally. Other Names: LY3484356 Drug: Quinidine Administered orally.
Experimental: Imlunestrant + Rosuvastatin & Digoxin Rosuvastatin administered in combination with digoxin administered orally on day 1 followed by imlunestrant administered orally in combination with rosuvastatin and digoxin orally on day 10.	Drug: Imlunestrant Administered orally. Other Names: LY3484356 Drug: Rosuvastatin Administered orally. Drug: Digoxin Administered orally.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide [Predose up to 24 hours postdose]
PK: AUC[0-∞] of Repaglinide
PK: Maximum Observed Concentration (Cmax) of Repaglinide [Predose up to 24 hours postdose]
PK: Cmax of Repaglinide
PK: AUC[0-∞] of Omeprazole [Predose up to 48 hours postdose]
PK: AUC[0-∞] of Omeprazole
PK: Cmax of Omeprazole [Predose up to 48 hours postdose]
PK: Cmax of Omeprazole
PK: AUC[0-∞] of 5-hydroxyomeprazole [Predose up to 48 hours postdose]
PK: AUC[0-∞] of 5-hydroxyomeprazole
PK: Cmax of 5-hydroxyomeprazole [Predose up to 48 hours postdose]
PK: Cmax of 5-hydroxyomeprazole
PK: AUC[0-∞] of Dextromethorphan [Predose up to 48 hours postdose]
PK: AUC[0-∞] of Dextromethorphan
PK: Cmax of Dextromethorphan [Predose up to 48 hours postdose]
PK: Cmax of Dextromethorphan
PK: AUC[0-∞] of Dextrorphan [Predose up to 48 hours postdose]
PK: AUC[0-∞] of Dextrorphan
PK: Cmax of Dextrorphan [Predose up to 48 hours postdose]
PK: Cmax of Dextrorphan
PK: AUC[0-∞] of Imlunestrant [Predose up to 168 hours postdose]
PK: AUC[0-∞] of Imlunestrant
PK: Cmax of Imlunestrant [Predose up to 168 hours postdose]
PK: Cmax of Imlunestrant
PK: AUC[0-∞] of Rosuvastatin [Predose up to 120 hours postdose]
PK: AUC[0-∞] of Rosuvastatin
PK: Cmax of Rosuvastatin [Predose up to 120 hours postdose]
PK: Cmax of Rosuvastatin
PK: AUC[0-∞] of Digoxin [Predose up to 120 hours postdose]
PK: AUC[0-∞] of Digoxin
PK: Cmax of Digoxin [Predose up to 120 hours postdose]
PK: Cmax of Digoxin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altasciences Clinical Los Angeles, Inc	Cypress	California	United States	90630
2	Qps-Mra, Llc	South Miami	Florida	United States	33143-4875
3	ICON Early Phase Services	San Antonio	Texas	United States	78209

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company