HealthyPhase 1NCT06814119
A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)
A Phase 1 study testing Calderasib in people with Healthy and Renal Impairment, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renal Impairment
- What is being tested?
- Calderasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2025to 6 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Research by Design ( Site 0001)
Chicago, Illinois, 60643
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, 32809
About this study
Official title: 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.
- Conditions
- Healthy, Renal Impairment
- Being tested
- Calderasib
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalderasibDrug
Also called MK-1084
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Panel A: Severe RI | Experimental | Participants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions. Receives: 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. Receives: Drug: Calderasib |
| Panel C: Healthy | Experimental | Healthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions. Receives: Drug: Calderasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At designated timepoints (up to approximately 2 days postdose)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At designated timepoints (up to approximately 1 day postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start7 Apr 2025
- Primary completion23 Jan 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814119
- Sponsor's protocol ID
- 1084-010
- Other IDs
- MK-1084-010
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Renal Impairment on the Single-Dose Pharmacokinetics of MK-1084
- ClinicalTrials.gov ID
- NCT06814119
- Acronym / sponsor ID
- 1084-010
- Conditions
- Healthy, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panel A: Severe RI | Experimental | Drug: CalderasibParticipants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions. |
| Panel B: Moderate RI | Experimental | Drug: CalderasibParticipants with moderate RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions. |
| Panel C: Healthy | Experimental | Drug: CalderasibHealthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has a BMI ≥18.0 and ≤40.0 kg/m^2
- 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
- Is medically healthy
Key exclusion criteria (8 listed)
- 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
- Has a history or presence of renal artery stenosis
- Has a renal transplant or nephrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalderasibAlso: MK-1084Oral tablet | Drug | Panel A: Severe RI, Panel B: Moderate RI, Panel C: Healthy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Number of Participants Who Experience an Adverse Event
Time frame: Up to approximately 2 weeks
Number of Participants Who Discontinue From the Study Due to an Adverse Event
Time frame: Up to approximately 2 weeks
Total Amount of calderasib Excreted Unchanged in Urine (Ae)
Time frame: At designated timepoints (up to approximately 1 day postdose)
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)
Fraction of calderasib Excreted Unchanged in Urine (fe)
Time frame: At designated timepoints (up to approximately 1 day postdose)
Renal Clearance (CLr) of calderasib
Time frame: At designated timepoints (up to approximately 1 day postdose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calderasib in people with Healthy and Renal Impairment, run by Merck Sharp & Dohme LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.