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

NCT06111521 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-11-08

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

LY3537982

Administered orally

DRUG

Digoxin

Administered orally

DRUG

Rosuvastatin

Administered orally

DRUG

Midazolam

Administered orally

DRUG

Midazolam

Administered IV

Sponsors & Collaborators

Principal Investigators

  • Yingying Guo-Avrutin · Loxo Oncology, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2024-04-01
Completion
2024-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06111521 on ClinicalTrials.gov