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Completed

NCT Number: NCT06814119

A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)

The goal of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of calderasib when it is given to people with RI and if people with RI can tolerate it.

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Key information

Conditions

Healthy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center ( Site 0002), Orlando, Florida, United States

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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:

All participants:

  • Has a BMI ≥18.0 and ≤40.0 kg/m^2

Participants with severe or moderate RI:

  • With the exception of RI, is sufficiently healthy for study participation
  • Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year

Participants with normal renal function:

  • Is medically healthy

Exclusion criteria

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

All participants:

  • Has a history of cancer (malignancy)
  • Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
  • Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing

Participants with severe or moderate RI:

  • Has a history or presence of renal artery stenosis
  • Has a renal transplant or nephrectomy

Treatment and study plan

Calderasib

Drug

Oral tablet

Other names: MK-1084

Primary outcomes

  1. 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.

  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.

  3. 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. 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.

  5. 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.

  6. 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. 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. 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. 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.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event

    Time frame: Up to approximately 2 weeks

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

  2. Number of Participants Who Discontinue From the Study Due to an Adverse Event

    Time frame: Up to approximately 2 weeks

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

  3. Total Amount of calderasib Excreted Unchanged in Urine (Ae)

    Time frame: At designated timepoints (up to approximately 1 day postdose)

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

  4. Total Amount of calderasib Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24)

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

    Urine samples will be collected to determine the Ae0-24 of calderasib.

  5. Fraction of calderasib Excreted Unchanged in Urine (fe)

    Time frame: At designated timepoints (up to approximately 1 day postdose)

    Urine samples will be collected to determine the fe of calderasib.

  6. Renal Clearance (CLr) of calderasib

    Time frame: At designated timepoints (up to approximately 1 day postdose)

    Urine samples will be collected to determine the CLr of calderasib.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effect of Renal Impairment on the Single-Dose Pharmacokinetics of MK-1084

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Feb 13, 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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