HealthyPhase 1NCT07222098
A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)
A Phase 1 study testing Rosuvastatin, Metformin and Calderasib in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
Researchers want to learn about calderasib when given with rosuvastatin and metformin in healthy people. The goal of this study is to compare the amount of rosuvastatin and metformin in a person's body over time when given with and without calderasib Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin, Metformin and Calderasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 29 Dec 2025
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has history of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of MK-1084 on the Single-Dose Pharmacokinetics of Rosuvastatin and Metformin in Healthy Participants
Researchers want to learn about calderasib when given with rosuvastatin and metformin in healthy people. The goal of this study is to compare the amount of rosuvastatin and metformin in a person's body over time when given with and without calderasib
- Conditions
- Healthy
- Being tested
- Rosuvastatin, Metformin, Calderasib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Oral tablet
MetforminDrug
Oral tablet
CalderasibDrug
Also called MK-1084
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin + metformin | Experimental | Participants will receive rosuvastatin plus metformin Receives: Drug: Rosuvastatin; Drug: Metformin |
| Rosuvastatin + metformin + Calderasib | Experimental | Participants will receive rosuvastatin plus metformin plus calderasib Receives: Drug: Rosuvastatin; Drug: Metformin; 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 Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
AUC0-inf of Metformin
Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Secondary outcomes (27)
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Rosuvastatin
Blood samples will be collected at multiple time points to estimate AUC0-24
Measured: Day 1: Predose and at designated timepoints up to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin
Blood samples will be collected at multiple time points to estimate Tmax
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin
Blood samples will be collected at multiple time points to estimate t1/2
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Apparent Clearance (CL/F) of Rosuvastatin
Blood samples will be collected at multiple time points to estimate CL/F
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin
Blood samples will be collected at multiple time points to estimate Vz/F
Measured: Day 1: Predose and at designated timepoints up to 120 hours post-dose
AUC0-last of Metformin
Blood samples will be collected at multiple time points to estimate AUC0-last
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-24hrs of Metformin
Blood samples will be collected at multiple time points to estimate AUC0-24
Measured: Day 1: Predose and at designated timepoints up to 24 hours post-dose
Cmax of Metformin
Blood samples will be collected at multiple time points to estimate Cmax
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Tmax of Metformin
Blood samples will be collected at multiple time points to estimate Tmax
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Metformin
Blood samples will be collected at multiple time points to estimate t1/2
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
CL/F of Metformin
Blood samples will be collected at multiple time points to estimate CL/F
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Vz/F of Metformin
Blood samples will be collected at multiple time points to estimate Vz/F
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of Calderasib
Blood samples will be collected at multiple time points to estimate AUC0-inf
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Calderasib
Blood samples will be collected at multiple time points to estimate AUC0-last
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-24hrs of Calderasib
Blood samples will be collected at multiple time points to estimate AUC0-24
Measured: Day 1: Predose and at designated timepoints up to 24 hours post-dose
Cmax of Calderasib
Blood samples will be collected at multiple time points to estimate Cmax
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Plasma Concentration at 24 Hours (C24) of Calderasib
Blood samples will be collected to estimate C24
Measured: 24 hours post-dose
Tmax of Calderasib
Blood samples will be collected at multiple time points to estimate Tmax
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Calderasib
Blood samples will be collected at multiple time points to estimate t1/2
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
CL/F of Calderasib
Blood samples will be collected at multiple time points to estimate CL/F
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Vz/F of Calderasib
Blood samples will be collected at multiple time points to estimate Vz/F
Measured: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Amount of Metformin Excreted Unchanged in Urine (Ae)
Urine samples will be collected at multiple time points to estimate Ae
Measured: Day 1: Predose and at designated timepoints up to 48 hours post-dose
Fraction of Metformin Excreted Unchanged in Urine (Fe)
Urine samples will be collected at multiple time points to estimate Fe
Measured: Day 1: Predose and at designated timepoints up to 48 hours post-dose
Renal Clearance of Metformin (CLr)
Urine samples will be collected at multiple time points to estimate CLr
Measured: Day 1: Predose and at designated timepoints up to 48 hours post-dose
Number of Participants Who Experience an Adverse Avent (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported.
Measured: Up to approximately 28 days after first dose
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported.
Measured: Up to approximately 14 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start19 Nov 2025
- Primary completion14 Dec 2025
- Study completion29 Dec 2025
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT07222098
- Sponsor's protocol ID
- 1084-016
- Other IDs
- MK-1084-016
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2025
- Last updated
- 6 May 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of MK-1084 on the Single-Dose Pharmacokinetics of Rosuvastatin and Metformin in Healthy Participants
- ClinicalTrials.gov ID
- NCT07222098
- Acronym / sponsor ID
- 1084-016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 29 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.
Researchers want to learn about calderasib when given with rosuvastatin and metformin in healthy people. The goal of this study is to compare the amount of rosuvastatin and metformin in a person's body over time when given with and without calderasib
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin + metformin | Experimental | Drug: Rosuvastatin, Drug: MetforminParticipants will receive rosuvastatin plus metformin |
| Rosuvastatin + metformin + Calderasib | Experimental | Drug: Rosuvastatin, Drug: Metformin, Drug: CalderasibParticipants will receive rosuvastatin plus metformin plus calderasib |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Key exclusion criteria (3 listed)
- Has history of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
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 |
|---|---|---|
| RosuvastatinOral tablet | Drug | Rosuvastatin + metformin, Rosuvastatin + metformin + Calderasib |
| MetforminOral tablet | Drug | Rosuvastatin + metformin, Rosuvastatin + metformin + Calderasib |
| CalderasibAlso: MK-1084Oral tablet | Drug | Rosuvastatin + metformin + Calderasib |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin
AUC0-inf of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin
27 secondary outcomes
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Apparent Clearance (CL/F) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin
Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose
AUC0-last of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-24hrs of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 24 hours post-dose
Cmax of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Tmax of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
CL/F of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Vz/F of Metformin
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-inf of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-last of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
AUC0-24hrs of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 24 hours post-dose
Cmax of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Plasma Concentration at 24 Hours (C24) of Calderasib
Time frame: 24 hours post-dose
Tmax of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
t1/2 of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
CL/F of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Vz/F of Calderasib
Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose
Amount of Metformin Excreted Unchanged in Urine (Ae)
Time frame: Day 1: Predose and at designated timepoints up to 48 hours post-dose
Fraction of Metformin Excreted Unchanged in Urine (Fe)
Time frame: Day 1: Predose and at designated timepoints up to 48 hours post-dose
Renal Clearance of Metformin (CLr)
Time frame: Day 1: Predose and at designated timepoints up to 48 hours post-dose
Number of Participants Who Experience an Adverse Avent (AE)
Time frame: Up to approximately 28 days after first dose
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 14 days after first dose
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 6 May 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin, Metformin and Calderasib in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site 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 2 inclusion and 3 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rosuvastatin (time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose). The study lists 3 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 6 May 2026.