A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Eli Lilly and Company113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

113

Conditions

Healthy

Interventions

ImlunestrantDRUG

Administered orally.

RepaglinideDRUG

Administered orally.

OmeprazoleDRUG

Administered orally.

Dextromethorphan

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (3)

Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

Qps-Mra, Llc

South Miami, Florida, United States

ICON Early Phase Services

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1)

PK: AUC\[0-∞\] of Repaglinide

Time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1)

PK: Cmax of Repaglinide

Time frame: Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

PK: AUC[0-∞] of Omeprazole (Cohort 2)

PK: AUC\[0-∞\] of Omeprazole