HealthyPhase 1NCT06619314
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-003)
A Phase 1 study testing Calderasib and PPI in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of calderasib in a person's body over time. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Calderasib and PPI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 25 Nov 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
- Medically healthy with no clinically significant medical history.
Who cannot join
- Has a history of cancer.
- Has had major surgery and/or donated or lost significant volume of blood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Part Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of calderasib in a person's body over time.
- Conditions
- Healthy
- Being tested
- Calderasib, PPI
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
PPIDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| Calderasib Treatment A | Experimental | Participants will receive calderasib on Day 1 on an empty stomach Receives: Drug: Calderasib |
| Calderasib Treatment B | Experimental | Participants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast Receives: Drug: Calderasib |
| Calderasib Treatment C | Experimental | Participants will receive calderasib Formulation 1 on Day 1 Receives: Drug: Calderasib |
| Calderasib Treatment D | Experimental | Participants will receive calderasib Formulation 2 on Day 1 Receives: Drug: Calderasib |
| Calderasib Treatment E | Experimental | Participants will receive calderasib without a PPI on Day 1 Receives: Drug: Calderasib |
| Calderasib Treatment F | Experimental | Participants will receive calderasib with a PPI on Day 5 Receives: Drug: Calderasib; Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food effect: Area Under the Concentration-Time Curve from 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 48 hours postdose)
Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Formulation Effect: Area Under the Concentration-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.
Measured: At designated timepoints (up to 48 hours postdose)
Formulation Effect: AUC0-inf of Calderasib
Blood samples will be collected to determine the AUC0-inf of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Formulation Effect: Area Under the Concentration-Time Curve from 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)
Formulation Effect: Cmax of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib
Blood samples will be collected to determine the C24 of calderasib.
Measured: 24 hours postdose
Formulation Effect: Lag Time (tlag) of Calderasib
Blood samples will be collected to determine the tlag of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Formulation Effect: 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 48 hours postdose)
Formulation Effect: 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 48 hours postdose)
Formulation Effect: Apparent Clearance (CL/F) of Calderasib
Blood samples will be collected to determine the CL/F of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Formulation Effect: 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 48 hours postdose)
Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib
Blood samples will be collected to determine the AUC0-inf of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: Cmax of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Secondary outcomes (22)
Food Effect: AUC0-last of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Food Effect: 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)
Food Effect: C24 of Calderasib
Blood samples will be collected to determine the C24 of calderasib.
Measured: 24 hours postdose
Food Effect: tlag of Calderasib
Blood samples will be collected to determine the tlag of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Food Effect: Tmax of Calderasib
Blood samples will be collected to determine the Tmax of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Food Effect: t1/2 of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Food Effect: CL/F of Calderasib
Blood samples will be collected to determine the CL/F of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Food Effect: Vz/F of Calderasib
Blood samples will be collected to determine the Vz/F of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)
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.
Measured: Up to approximately 2 months
Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
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.
Measured: Up to approximately 2 months
Formulation Effect: Number of Participants Who Experience a TEAE
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.
Measured: Up to approximately 2 months
Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
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.
Measured: Up to approximately 2 months
PPI Effect: AUC0-last of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: 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)
PPI Effect: C24 of Calderasib
Blood samples will be collected to determine the C24 of calderasib.
Measured: 24 hours postdose
PPI Effect: tlag of Calderasib
Blood samples will be collected to determine the tlag of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: Tmax of Calderasib
Blood samples will be collected to determine the Tmax of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: t1/2 of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: CL/F of Calderasib
Blood samples will be collected to determine the CL/F of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: Vz/F of Calderasib
Blood samples will be collected to determine the Vz/F of calderasib.
Measured: At designated timepoints (up to 48 hours postdose)
PPI Effect: Number of Participants Who Experience a TEAE
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.
Measured: Up to approximately 2 months
PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
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.
Measured: Up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start20 Sep 2023
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
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
- 56 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
- NCT06619314
- Sponsor's protocol ID
- 1084-003
- Other IDs
- MK-1084-003
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2024
- Last updated
- 11 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06619314
- Acronym / sponsor ID
- 1084-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 1 Oct 2024 (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 evaluate the effect of food, formulation, and a PPI on the levels of calderasib in a person's body over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Calderasib Treatment A | Experimental | Drug: CalderasibParticipants will receive calderasib on Day 1 on an empty stomach |
| Calderasib Treatment B | Experimental | Drug: CalderasibParticipants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast |
| Calderasib Treatment C | Experimental | Drug: CalderasibParticipants will receive calderasib Formulation 1 on Day 1 |
| Calderasib Treatment D | Experimental | Drug: CalderasibParticipants will receive calderasib Formulation 2 on Day 1 |
| Calderasib Treatment E | Experimental | Drug: CalderasibParticipants will receive calderasib without a PPI on Day 1 |
| Calderasib Treatment F | Experimental | Drug: Calderasib, Drug: PPIParticipants will receive calderasib with a PPI on Day 5 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
- Medically healthy with no clinically significant medical history.
Key exclusion criteria (2 listed)
- Has a history of cancer.
- Has had major surgery and/or donated or lost significant volume of blood.
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 Treatment A, Calderasib Treatment B, Calderasib Treatment C, Calderasib Treatment D, Calderasib Treatment E, Calderasib Treatment F |
| PPIOral Capsule | Drug | Calderasib Treatment F |
Primary outcome
Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
Formulation Effect: AUC0-inf of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
Formulation Effect: Area Under the Concentration-Time Curve from 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.
Formulation Effect: Cmax of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib
Time frame: 24 hours postdose
Blood samples will be collected to determine the C24 of calderasib.
Formulation Effect: Lag Time (tlag) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the tlag of calderasib.
Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Tmax of calderasib.
Formulation Effect: Apparent Terminal Half-Life (t1/2) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
Formulation Effect: Apparent Clearance (CL/F) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the CL/F of calderasib.
Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
PPI Effect: Cmax of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
22 secondary outcomes
Food Effect: AUC0-last of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Food Effect: AUC0-24 of Calderasib
Time frame: At designated timepoints (up to 24 hours postdose)
Food Effect: C24 of Calderasib
Time frame: 24 hours postdose
Food Effect: tlag of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Food Effect: Tmax of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Food Effect: t1/2 of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Food Effect: CL/F of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Food Effect: Vz/F of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 2 months
Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
Time frame: Up to approximately 2 months
Formulation Effect: Number of Participants Who Experience a TEAE
Time frame: Up to approximately 2 months
Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
Time frame: Up to approximately 2 months
PPI Effect: AUC0-last of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
PPI Effect: AUC0-24 of Calderasib
Time frame: At designated timepoints (up to 24 hours postdose)
PPI Effect: C24 of Calderasib
Time frame: 24 hours postdose
PPI Effect: tlag of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
PPI Effect: Tmax of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
PPI Effect: t1/2 of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
PPI Effect: CL/F of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
PPI Effect: Vz/F of Calderasib
Time frame: At designated timepoints (up to 48 hours postdose)
PPI Effect: Number of Participants Who Experience a TEAE
Time frame: Up to approximately 2 months
PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
Time frame: Up to approximately 2 months
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 11 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
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 Calderasib and PPI 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 2 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 11 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 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?
Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib (time frame: At designated timepoints (up to 48 hours postdose)). The study lists 14 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 11 Feb 2026.