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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Renal Impairment
• Intervention / Treatment: Drug: Calderasib

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center ( Site 0002)
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A: Severe RI; Participants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.	Drug: Calderasib; Oral tablet; Other Names: MK-1084
Experimental: Panel B: Moderate RI; Participants with moderate RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.	Drug: Calderasib; Oral tablet; Other Names: MK-1084
Experimental: Panel C: Healthy; Healthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions.	Drug: Calderasib; Oral tablet; Other Names: MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of calderasib	Blood samples will be collected to determine the AUC0-inf of calderasib.	At designated timepoints (up to approximately 2 days postdose)
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of calderasib	Blood samples will be collected to determine the AUC0-last of calderasib.	At designated timepoints (up to approximately 2 days postdose)
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of calderasib	Blood samples will be collected to determine the AUC0-24 of calderasib.	At designated timepoints (up to 24 hours postdose)
Plasma Concentration of calderasib at 24 Hours Postdose (C24)	Blood samples will be collected to determine the C24 of calderasib.	At designated timepoints (up to 24 hours postdose)
Maximum Plasma Concentration (Cmax) of calderasib	Blood samples will be collected to determine the Cmax of calderasib.	At designated timepoints (up to approximately 2 days postdose)
Time to Maximum Plasma Concentration (Tmax) of calderasib	Blood samples will be collected to determine the Tmax of calderasib.	At designated timepoints (up to approximately 2 days postdose)
Apparent Terminal Half-life (t1/2) of calderasib	Blood samples will be collected to determine the t1/2 of calderasib.	At designated timepoints (up to approximately 2 days postdose)
Apparent Clearance (CL/F) of calderasib	Blood samples will be collected to determine the CL/F of calderasib.	At designated timepoints (up to approximately 2 days postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of calderasib	Blood samples will be collected to determine the Vz/F of calderasib.	At designated timepoints (up to approximately 2 days postdose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event	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.	Up to approximately 2 weeks
Number of Participants Who Discontinue From the Study Due to an Adverse Event	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.	Up to approximately 2 weeks
Total Amount of calderasib Excreted Unchanged in Urine (Ae)	Urine samples will be collected to determine the Ae of calderasib.	At designated timepoints (up to approximately 1 day postdose)
Total Amount of calderasib Excreted Unchanged in Urine From 0 to 24 Hours (Ae0-24)	Urine samples will be collected to determine the Ae0-24 of calderasib.	At designated timepoints (up to 24 hours postdose)
Fraction of calderasib Excreted Unchanged in Urine (fe)	Urine samples will be collected to determine the fe of calderasib.	At designated timepoints (up to approximately 1 day postdose)
Renal Clearance (CLr) of calderasib	Urine samples will be collected to determine the CLr of calderasib.	At designated timepoints (up to approximately 1 day postdose)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): February 6, 2026

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: 1084-010; MK-1084-010 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No