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

NCT06575933 | Completed Phase 1 FDA Drug

• 3 other identifiers: 1084-009CA43815MK-1084-009
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (16)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam

  Blood samples will be collected to determine the AUC0-inf of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Midazolam

  Blood samples will be collected to determine the AUC0-last of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of Midazolam

  Blood samples will be collected to determine the AUC0-24hr of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Maximum Plasma Concentration (Cmax) of Midazolam

  Blood samples will be collected to determine the Cmax of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Time to Maximum Plasma Concentration (Tmax) of Midazolam

  Blood samples will be collected to determine the Tmax of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Apparent Terminal Half-life (t1/2) of Midazolam

  Blood samples will be collected to determine the t1/2 of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Apparent Clearance (CL/F) of Midazolam

  Blood samples will be collected to determine the CL/F of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam

  Blood samples will be collected to determine the Vz/F of midazolam.

  Predose and at designated timepoints up to 24 hours postdose

• AUC0-Inf of Digoxin

  Blood samples will be collected to determine the AUC0-inf of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

• AUC0-Last of Digoxin

  Blood samples will be collected to determine the AUC0-last of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

• AUC0-24hr of Digoxin

  Blood samples will be collected to determine the AUC0-24hr of digoxin.

  Predose and at designated timepoints up to 24 hours postdose

• Cmax of Digoxin

  Blood samples will be collected to determine the Cmax of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

• Tmax of Digoxin

  Blood samples will be collected to determine the Tmax of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

• t1/2 of Digoxin

  Blood samples will be collected to determine the t1/2 of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

• CL/F of Digoxin

  Blood samples will be collected to determine the CL/F of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

• Vz/F of Digoxin

  Blood samples will be collected to determine the Vz/F of digoxin.

  Predose and at designated timepoints up to 120 hours postdose

Secondary Outcomes (13)

• AUC0-24hr of Calderasib

  Predose and at designated timepoints up to 24 hours postdose

• AUC0-Last of Calderasib

  Predose and at designated timepoints up to 24 hours postdose

• Cmax of Calderasib

  Predose and at designated timepoints up to 24 hours postdose

• C24 of Calderasib

  Predose and at designated timepoints up to 24 hours postdose

• Tmax of Calderasib

  Predose and at designated timepoints up to 24 hours postdose

Study Arms (2)

Period 1: Midazolam and Digoxin

EXPERIMENTAL

Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1.

Drug: Midazolam; Drug: Digoxin

Period 2: Calderasib, Midazolam, and Digoxin

EXPERIMENTAL

A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first calderasib dosing in Period 2. Participants will receive calderasib once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11.

Drug: Calderasib; Drug: Midazolam; Drug: Digoxin

Interventions

Midazolam DRUG

Oral administration

Period 1: Midazolam and Digoxin; Period 2: Calderasib, Midazolam, and Digoxin

Digoxin DRUG

Oral administration

Period 1: Midazolam and Digoxin; Period 2: Calderasib, Midazolam, and Digoxin

Calderasib DRUG

Oral administration

Also known as: MK-1084

Period 2: Calderasib, Midazolam, and Digoxin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)
• Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

You may not qualify if:

• Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
• Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Midazolam; Digoxin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 3, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)