A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Repaglinide; Drug: Rosuvastatin; Drug: Digoxin; Drug: Imlunestrant; Drug: Quinidine; Drug: Dextromethorphan; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05444556

J2J-MC-JZLI (Other Identifier)

18413

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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113 participants in 4 patient groups

Imlunestrant + Repaglinide (Cohort 1)

Experimental group

Description:

Participants received: Day 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally.

Treatment:

Drug: Imlunestrant

Drug: Repaglinide

mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)

Experimental group

Description:

Participants received: Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning. Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally.

Treatment:

Drug: Omeprazole

Drug: Dextromethorphan

Drug: Imlunestrant

Imlunestrant + Quinidine (Cohort 3)

Experimental group

Description:

Participants received: Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone. Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen).

Treatment:

Drug: Quinidine

Drug: Imlunestrant

Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)

Experimental group

Description:

Participants received: Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning. Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally.

Treatment:

Drug: Imlunestrant

Drug: Digoxin

Drug: Rosuvastatin