NCT06575933

A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)

A Study to Evaluate the Effect of Single and Multiple Doses of MK-1084 on the Single-Dose Pharmacokinetics of Midazolam and Digoxin in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called calderasib. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without calderasib.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Calderasib	Oral administration
DRUG	Midazolam	Oral administration
DRUG	Digoxin	Oral administration

Timeline

• Start date: 2024-09-03
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2024-08-28
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study