A Drug-Drug Interaction Study of LY3537982 on Midazolam, Digoxin, and Rosuvastatin in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-04-01

Brief Summary

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The main purpose of this study is to evaluate the effects of multiple doses of LY3537982 on the pharmacokinetics (PK) of digoxin (a P-glycoprotein \[P-gp\] substrate), rosuvastatin (a breast cancer resistance protein \[BCRP)\] substrate), and midazolam (a substrate of Cytochrome P450 3A4 \[CYP3A4\]) in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982 with or without single doses of digoxin, rosuvastatin, and midazolam. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 23 and 11 days for part 1 and part 2, respectively, not including screening.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3537982 + Digoxin & Rosuvastatin (Part 1)

Single oral doses of digoxin and rosuvastatin with or without multiple doses of LY3537982 administered orally

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally

Digoxin

Intervention Type DRUG

Administered orally

Rosuvastatin

Intervention Type DRUG

Administered orally

LY3537982 + Midazolam (Part 2)

Single doses of midazolam administered either orally or intravenously (IV) with or without multiple doses of LY3537982 administered orally

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally

Midazolam

Intervention Type DRUG

Administered orally

Midazolam

Intervention Type DRUG

Administered IV

Interventions

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LY3537982

Administered orally

Intervention Type DRUG

Digoxin

Administered orally

Intervention Type DRUG

Rosuvastatin

Administered orally

Intervention Type DRUG

Midazolam

Administered orally

Intervention Type DRUG

Midazolam

Administered IV

Intervention Type DRUG

Other Intervention Names

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Olomorasib

Eligibility Criteria

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Inclusion Criteria

* Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
* Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive