Skip to main content
OpenTrials
Completed

NCT Number: NCT06719557

A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)

The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

  • Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion criteria

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

  • History of cancer (malignancy)
  • Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Part 1 Only:

  • History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)

Pat 2 Only:

  • History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions

Treatment and study plan

Calderasib

Drug

Oral Tablet

Other names: MK-1084

Itraconazole

Drug

Oral solution

Phenytoin

Drug

Oral capsule (extended)

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

Secondary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of Calderasib

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

  2. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib

    Time frame: Pre-dose and at designated time points up to 24 hours post dose

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

  3. Maximum Plasma Concentration (Cmax) of Calderasib

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

  4. Plasma Concentration at 24 Hours (C24) of Calderasib

    Time frame: Pre-dose and at designated time points up to 24 hours post dose

    Blood samples will be collected to determine the C24 of calderasib.

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

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

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

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

  7. Apparent Clearance (CL/F) of Calderasib

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

  8. Apparent volume of distribution during terminal phase (Vz/F) of Calderasib

    Time frame: Pre-dose and at designated time points up to 72 hours post dose

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

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

    Time frame: Up to approximately 41 days

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

  10. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 25 days

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Two-Part Study to Evaluate the Effects of Multiple Doses of Itraconazole and Multiple Doses of Phenytoin on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.