HealthyPhase 1NCT06719557
A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)
A Phase 1 study testing Calderasib, Itraconazole and Phenytoin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin. 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, Itraconazole and Phenytoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 30 Jul 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 19 to 55 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 kg/m^2 and ≤32 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Part 1 Only:
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)
- Pat 2 Only:
- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Study to Evaluate the Effects of Multiple Doses of Itraconazole and Multiple Doses of Phenytoin on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.
- Conditions
- Healthy
- Being tested
- Calderasib, Itraconazole, Phenytoin
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
ItraconazoleDrug
Oral solution
PhenytoinDrug
Oral capsule (extended)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Calderasib + Itraconazole | Experimental | Part 1: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of calderasib administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2. Receives: Drug: Calderasib; Drug: Itraconazole |
| Part 2: Calderasib + Phenytoin | Experimental | Part 2: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of calderasib co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2. Receives: Drug: Calderasib; Drug: Phenytoin |
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 After Single Dosing (AUC0-Inf) of Calderasib
Blood samples will be collected to determine the AUC0-Inf of calderasib.
Measured: Pre-dose and at designated time points up to 72 hours post dose
Secondary outcomes (10)
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib.
Measured: Pre-dose and at designated time points up to 72 hours post dose
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: Pre-dose and at designated time points up to 24 hours post dose
Maximum Plasma Concentration (Cmax) of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: Pre-dose and at designated time points up to 72 hours post dose
Plasma Concentration at 24 Hours (C24) of Calderasib
Blood samples will be collected to determine the C24 of calderasib.
Measured: Pre-dose and at designated time points up to 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Calderasib
Blood samples will be collected to determine the Tmax of calderasib.
Measured: Pre-dose and at designated time points up to 72 hours post dose
Apparent Terminal Half-life (t1/2) of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib.
Measured: Pre-dose and at designated time points up to 72 hours post dose
Apparent Clearance (CL/F) of Calderasib
Blood samples will be collected to determine the CL/F of calderasib.
Measured: Pre-dose and at designated time points up to 72 hours 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.
Measured: Pre-dose and at designated time points up to 72 hours post dose
Number of Participants Who Experience an Adverse Event (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. The number of participants who experience an AE will be reported.
Measured: Up to approximately 41 days
Number of Participants Who Discontinue Study Treatment 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. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start20 May 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT06719557
- Sponsor's protocol ID
- 1084-008
- Other IDs
- MK-1084-008, CA43207
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 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 Two-Part Study to Evaluate the Effects of Multiple Doses of Itraconazole and Multiple Doses of Phenytoin on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06719557
- Acronym / sponsor ID
- 1084-008
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 6 Dec 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 goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Calderasib + Itraconazole | Experimental | Drug: Calderasib, Drug: ItraconazolePart 1: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive itraconazole once daily (QD) for 7 consecutive days (Day 1 - Day 7), plus a single dose of calderasib administered approximately 2 hours after itraconazole dosing on Day 5. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2. |
| Part 2: Calderasib + Phenytoin | Experimental | Drug: Calderasib, Drug: PhenytoinPart 2: In Period 1 participants receive a single dose of calderasib on Day 1 under fasting conditions. In Period 2 participants receive phenytoin three times daily (TID) for 14 consecutive days (Day 1 - Day 14), plus a single dose of calderasib co-administered on the morning of Day 13. There will be a washout of at least 7 days between dosing in Period 1 and the first dose in Period 2. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2
Key exclusion criteria (7 listed)
- History of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)
- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions
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 | Part 1: Calderasib + Itraconazole, Part 2: Calderasib + Phenytoin |
| ItraconazoleOral solution | Drug | Part 1: Calderasib + Itraconazole |
| PhenytoinOral capsule (extended) | Drug | Part 2: Calderasib + Phenytoin |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Blood samples will be collected to determine the AUC0-Inf of calderasib.
10 secondary outcomes
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib
Time frame: Pre-dose and at designated time points up to 24 hours post dose
Maximum Plasma Concentration (Cmax) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Plasma Concentration at 24 Hours (C24) of Calderasib
Time frame: Pre-dose and at designated time points up to 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Apparent Terminal Half-life (t1/2) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Apparent Clearance (CL/F) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Apparent volume of distribution during terminal phase (Vz/F) of Calderasib
Time frame: Pre-dose and at designated time points up to 72 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 41 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 25 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 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, Itraconazole and Phenytoin 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 7 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?
Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib (time frame: Pre-dose and at designated time points up to 72 hours post dose). 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.