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

NCT06814119 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1084-010MK-1084-010
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy; Renal Impairment

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Number of Participants Who Experience an Adverse Event

  Up to approximately 2 weeks

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

  Up to approximately 2 weeks

• Total Amount of calderasib Excreted Unchanged in Urine (Ae)

  At designated timepoints (up to approximately 1 day postdose)

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

  At designated timepoints (up to 24 hours postdose)

• Fraction of calderasib Excreted Unchanged in Urine (fe)

  At designated timepoints (up to approximately 1 day postdose)

Study Arms (3)

Panel A: Severe RI

EXPERIMENTAL

Participants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.

Drug: Calderasib

Panel B: Moderate RI

EXPERIMENTAL

Participants with moderate RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.

Drug: Calderasib

Panel C: Healthy

EXPERIMENTAL

Healthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions.

Drug: Calderasib

Interventions

Calderasib DRUG

Oral tablet

Also known as: MK-1084

Panel A: Severe RI; Panel B: Moderate RI; Panel C: Healthy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, 32809, United States

Location

Research by Design ( Site 0001)

Chicago, Illinois, 60643, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: April 7, 2025
• Primary Completion: January 23, 2026
• Study Completion: February 6, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)