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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3537982; Drug: Midazolam; Drug: Rosuvastatin; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06111521

J3M-OX-JZQJ (Other Identifier)

LOXO-RAS-23007

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

LY3537982 + Digoxin & Rosuvastatin (Part 1)

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: Digoxin

Drug: LY3537982

LY3537982 + Midazolam (Part 2)

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Drug: Midazolam

Drug: LY3537982