HealthyPhase 1NCT07219550
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
A Phase 1 study testing Calderasib in people with Healthy and Hepatic Impairment, run by Merck Sharp & Dohme LLC at 3 sites in United States.
Trial summary
The purpose 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 participants with hepatic (liver) impairment and healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatic 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
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Nov 2025to 15 Jul 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The main inclusion criteria include but are not limited to:
All participants:
- Has a body mass index (BMI) between 18.0 and 42.0 kg/m^2
Participants with hepatic impairment (HI):
- Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis
Healthy volunteers:
- Is medically healthy with no clinically significant medical history
The main exclusion criteria include but are not limited to:
All participants:
- Has a history of gastrointestinal disease which may affect food and drug absorption
- Has a history of cancer (malignancy)
- Has a positive result for human immunodeficiency virus (HIV)
- Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing
Participants with HI:
- Has had severe complications of liver disease within the preceding 3 months of screening
- Has a history of recent (within 3 months prior to screening) variceal bleeds
- Has evidence of hepatorenal syndrome
- Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of < 3 months
- Has a history of liver or other solid organ transplantation
- Has an active infection requiring systemic therapy
- Requires paracentesis more often than 2 times per month
- Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
- Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing
- Is using HIV protease inhibitors
- Is positive for Hepatitis B surface antigen (HBsAg)
- Is positive for HCV
Healthy volunteers:
- Has positive results for HBsAg or HCV
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arizona Clinical Trials ( Site 0003)
Chandler, Arizona, 85225
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, 32809
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, 78215
About this study
Official title: A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
The purpose 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 participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.
- Conditions
- Healthy, Hepatic Impairment
- Being tested
- Calderasib
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 |
|---|---|---|
| Calderasib | Experimental | All participants will receive a single oral dose of calderasib on Day 1. Receives: Drug: Calderasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib
Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.
Measured: Up to approximately 24 hours post-dose
Maximum Observed Drug Concentration (Cmax) of Calderasib
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Time to Maximum Observed Drug Concentration (Tmax) of Calderasib
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Apparent Terminal Half-life (t1/2) of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Apparent Clearance (CL/F) of Calderasib
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
Measured: At designated timepoints up to approximately 7 days post-dose
Secondary outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.
Measured: Up to approximately 14 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.
Measured: Up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start5 Nov 2025
- Primary completion15 Jul 2026
- Study completion15 Jul 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT07219550
- Sponsor's protocol ID
- 1084-017
- Other IDs
- MK-1084-017
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2025
- Last updated
- 4 Aug 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084
- ClinicalTrials.gov ID
- NCT07219550
- Acronym / sponsor ID
- 1084-017
- Conditions
- Healthy, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 22 Oct 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 purpose 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 participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calderasib | Experimental | Drug: CalderasibAll participants will receive a single oral dose of calderasib on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 | Calderasib |
Primary outcome
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib
Time frame: Up to approximately 24 hours post-dose
Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.
Maximum Observed Drug Concentration (Cmax) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Time to Maximum Observed Drug Concentration (Tmax) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Apparent Terminal Half-life (t1/2) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Apparent Clearance (CL/F) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Time frame: At designated timepoints up to approximately 7 days post-dose
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 14 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 14 days
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 4 Aug 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
3 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 Hepatic Impairment, run by Merck Sharp & Dohme LLC at 3 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?
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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib (time frame: At designated timepoints up to approximately 7 days post-dose). The study lists 8 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 4 Aug 2026.