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Completed

NCT Number: NCT06575933

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

  • 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

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

  • 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

Treatment and study plan

Calderasib

Drug

Oral administration

Other names: MK-1084

midazolam

Drug

Oral administration

Digoxin

Drug

Oral administration

Primary outcomes

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

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

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

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

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

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  4. Maximum Plasma Concentration (Cmax) of Midazolam

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  5. Time to Maximum Plasma Concentration (Tmax) of Midazolam

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

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

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  7. Apparent Clearance (CL/F) of Midazolam

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

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

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  9. AUC0-Inf of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

  10. AUC0-Last of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

  11. AUC0-24hr of Digoxin

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  12. Cmax of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

  13. Tmax of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

  14. t1/2 of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

  15. CL/F of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

  16. Vz/F of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

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

Secondary outcomes

  1. AUC0-24hr of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  2. AUC0-Last of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  3. Cmax of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  4. C24 of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  5. Tmax of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  6. t1/2 of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

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

  7. Cmax Accumulation Ratio of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the Cmax accumulation ratio of calderasib. The accumulation ratio is the ratio of Predose Cmax to the 24 hour Cmax

  8. AUC0-24 Accumulation Ratio of Calderasib

    Time frame: Predose and at designated timepoints up to 24 hours postdose

    Blood samples will be collected to determine the AUC0-24 accumulation ratio of calderasib. The accumulation ratio is the ratio of Predose AUC0-24 to the 24 hour AUC0-24.

  9. Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

    Urine samples will be collected to determine the Aet1-t2 of digoxin.

  10. Total Amount of Drug Excreted in Urine (Ae) of Digoxin

    Time frame: Predose and at designated timepoints up to 120 hours postdose

    Urine samples will be collected to determine the Ae of digoxin.

  11. Fraction of Unchanged Digoxin in Urine (Fe)

    Time frame: Predose and at designated timepoints up to 120 hours postdose

    Urine samples will be collected to determine the Fe of digoxin.

  12. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 1 month

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  13. Number of Participants Who Discontinue Study Due to an AE

    Time frame: Up to approximately 1 month

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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