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Completed

NCT Number: NCT06942741

A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011)

This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are:

* In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets * In Part 2, to learn what happens to calderasib in a person's blood when it is taken on an empty stomach or after a meal

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Key information

Conditions

Healthy

Age range

18 year–60 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 main inclusion criteria include but are not limited to the following:

  • Has a body mass index ≥18.0 and ≤32.0 kg/m^2

Exclusion criteria

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

  • Has a history or presence of a clinically significant medical or psychiatric condition or disease
  • Has a history of cancer (malignancy)
  • Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus

Treatment and study plan

Calderasib OCT

Drug

Oral tablet

Other names: MK-1084 OCT

Calderasib FCT

Drug

Oral tablet

Other names: MK-1084 FCT

Primary outcomes

  1. Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  2. Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  3. Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib

    Time frame: At designated timepoints (up to 24 hours postdose)

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

  4. Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  5. Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24)

    Time frame: At designated timepoints (up to 24 hours postdose)

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

  6. Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  7. Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  8. Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  9. Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

  10. Part 2: Plasma Lag Time (tlag) of Calderasib

    Time frame: At designated timepoints (up to approximately 2 days postdose)

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

Secondary outcomes

  1. Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 7 weeks

    An AE is any untoward medical occurrence in a clinical study 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

  2. Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 1 week

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue from the 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 Determine Bioequivalence Between the MK-1084 Film-Coated Tablet and Oral-Compressed Tablet and the Effect of Food on the Single-Dose Pharmacokinetics of the MK-1084 Film-Coated Tablet in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
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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