A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2022-11-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Imlunestrant + Repaglinide (Cohort 1)

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.

Group Type EXPERIMENTAL

Imlunestrant

Intervention Type DRUG

Administered orally.

Repaglinide

Intervention Type DRUG

Administered orally.

mlunestrant + Omeprazole & Dextromethorphan (Cohort 2)

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.

Group Type EXPERIMENTAL

Imlunestrant

Intervention Type DRUG

Administered orally.

Omeprazole

Intervention Type DRUG

Administered orally.

Dextromethorphan

Intervention Type DRUG

Administered orally.

Imlunestrant + Quinidine (Cohort 3)

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).

Group Type EXPERIMENTAL

Imlunestrant

Intervention Type DRUG

Administered orally.

Quinidine

Intervention Type DRUG

Administered orally.

Imlunestrant + Rosuvastatin & Digoxin (Cohort 4)

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.

Group Type EXPERIMENTAL

Imlunestrant

Intervention Type DRUG

Administered orally.

Rosuvastatin

Intervention Type DRUG

Administered orally.

Digoxin

Intervention Type DRUG

Administered orally.

Interventions

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Imlunestrant

Administered orally.

Intervention Type DRUG

Repaglinide

Administered orally.

Intervention Type DRUG

Omeprazole

Administered orally.

Intervention Type DRUG

Dextromethorphan

Administered orally.

Intervention Type DRUG

Quinidine

Administered orally.

Intervention Type DRUG

Rosuvastatin

Administered orally.

Intervention Type DRUG

Digoxin

Administered orally.

Intervention Type DRUG

Other Intervention Names

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LY3484356

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes