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

Eli Lilly and Company35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: * Females who are lactating or of childbearing potential * Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Outcomes

Primary Outcomes

Part 1: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982

Part 1: PK: Cmax of LY3537982

Time frame: Predose on day 11 up to day 17

Part 1: PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982

Part 1: PK: AUC\[0-inf\] of LY3537982

Time frame: Predose on day 11 up to day 17

Part 1: PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982

Part 1: PK: AUClast of LY3537982

Time frame: Predose on day 11 up to day 17

Part 1: PK: Cmax of Digoxin