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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy

Treatments: Drug: Calderasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06814119

MK-1084-010 (Other Identifier)

1084-010

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Panel A: Severe RI

Experimental group

Description:

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

Treatment:

Drug: Calderasib

Panel B: Moderate RI

Experimental group

Description:

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

Treatment:

Drug: Calderasib

Panel C: Healthy

Experimental group

Description:

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

Treatment:

Drug: Calderasib