HealthyPhase 1NCT06687759
A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006)
A Phase 1 study testing [14C]Calderasib 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 learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]Calderasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2024to 7 Aug 2024
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
- Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has a history of cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortea CRU Madison (Site 0001)
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]MK-1084 in Healthy Adult Participants
The purpose of this study is to learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.
- Conditions
- Healthy
- Being tested
- [14C]Calderasib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]CalderasibDrug
Also called MK-1084
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Carbon-14 radiolabeled [14C] MK-1084 | Experimental | Participants receive single oral dose of calderasib on Day 1. Receives: Drug: [14C]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 plasma Calderasib
Bood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib
Blood samples will be collected to determine the AUC0-24 of plasma calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Maximum Concentration (Cmax) of plasma Calderasib
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Concentration at 24 hours postdose (C24) of plasma Calderasib
Blood samples will be collected to determine the C24 of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Time to Reach Maximum Concentration (Tmax) of plasma Calderasib
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Apparent Half Life (t½) of plasma Calderasib
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Apparent Total Clearance (CL/F) of plasma Calderasib
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma Calderasib
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
AUC0-inf/Total Radioactivity Ratio of plasma Calderasib
Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of calderasib in plasma.
Measured: Predose and at designated timepoints up to Day 15
Amount Excreted in the Urine (Aeu) of Calderasib
Urine samples will be collected to determine the Aeu of calderasib
Measured: Predose and at designated timepoints up to Day 15
Cumulative Aeu of Calderasib
Urine samples will be collected to determine the cumulative Ae of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Percentage Excreted in the Urine (feu) of Calderasib
Urine samples will be collected to determine the feu of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Cumulative feu of Calderasib
Urine samples will be collected to determine the cumulative feu of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Amount Excreted in the Feces (Aef) of Calderasib
Feces samples will be collected to determine the Aef of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Cumulative Aef of Calderasib
Feces samples will be collected to determine the cumulative Aef of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Percentage Excreted in the Feces (fef) of Calderasib
Feces samples will be collected to determine the fef of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Cumulative fef of Calderasib
Feces samples will be collected to determine the cumulative fef of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Metabolites in Plasma of Calderasib
Blood samples will be collected to determine the metabolites of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Metabolites in Urine of Calderasib
Urine samples will be collected to determine the metabolites of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Metabolites in Feces of Calderasib
Feces samples will be collected to determine the metabolites of calderasib.
Measured: Predose and at designated timepoints up to Day 15
Secondary outcomes (2)
Number of Participants Experiencing an Adverse Event (AE)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Measured: Up to ~ 28 days
Number of Participants Discontinuing Study Treatment due to an AE
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Measured: Up to ~ 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start26 Jun 2024
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687759
- Sponsor's protocol ID
- 1084-006
- Other IDs
- MK-1084-006
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2024
- Last updated
- 13 Apr 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of [14C]MK-1084 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06687759
- Acronym / sponsor ID
- 1084-006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 14 Nov 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 learn what happens to calderasib in a healthy person's body over time and how it is cleared from the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon-14 radiolabeled [14C] MK-1084 | Experimental | Drug: [14C]CalderasibParticipants receive single oral dose of calderasib on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health based on medical history, physical examination,vital signs measurements, and electrocardiogram (ECG)s performed before randomization.
- Has a body mass index (BMI) 18 to 32 kg/m2, inclusive, at screening
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- Has a history of cancer.
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 |
|---|---|---|
| [14C]CalderasibAlso: MK-1084Oral administration | Drug | Carbon-14 radiolabeled [14C] MK-1084 |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Bood samples will be collected to determine the AUC0-inf of calderasib in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-24 of plasma calderasib in plasma.
Maximum Concentration (Cmax) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of calderasib in plasma.
Concentration at 24 hours postdose (C24) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the C24 of calderasib in plasma.
Time to Reach Maximum Concentration (Tmax) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of calderasib in plasma.
Apparent Half Life (t½) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
Apparent Total Clearance (CL/F) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the CL/F of calderasib in plasma.
Apparent Volume of Distribution during the Terminal Elimination Phase (Vz/F) of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
AUC0-inf/Total Radioactivity Ratio of plasma Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf/Total Radioactivity Ratio of calderasib in plasma.
Amount Excreted in the Urine (Aeu) of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Aeu of calderasib
Cumulative Aeu of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative Ae of calderasib.
Percentage Excreted in the Urine (feu) of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the feu of calderasib.
Cumulative feu of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the cumulative feu of calderasib.
Amount Excreted in the Feces (Aef) of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Aef of calderasib.
Cumulative Aef of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative Aef of calderasib.
Percentage Excreted in the Feces (fef) of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the fef of calderasib.
Cumulative fef of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the cumulative fef of calderasib.
Metabolites in Plasma of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of calderasib.
Metabolites in Urine of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of calderasib.
Metabolites in Feces of Calderasib
Time frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of calderasib.
2 secondary outcomes
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to ~ 28 days
Number of Participants Discontinuing Study Treatment due to an AE
Time frame: Up to ~ 28 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 13 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]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 3 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 13 Apr 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 plasma Calderasib (time frame: Predose and at designated timepoints up to Day 15). The study lists 21 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 Apr 2026.