Non-small Cell Lung CancerPhase 1NCT06575933
A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
A Phase 1 study testing Calderasib, Midazolam and Digoxin in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called calderasib. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Calderasib, Midazolam and Digoxin
- 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
- 3 Sep 2024to 28 Oct 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
- Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Single and Multiple Doses of MK-1084 on the Single-Dose Pharmacokinetics of Midazolam and Digoxin in Healthy Participants
The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called calderasib. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without calderasib.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Calderasib, Midazolam, Digoxin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 administration
MidazolamDrug
Oral administration
DigoxinDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Midazolam and Digoxin | Experimental | Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1. Receives: Drug: Midazolam; Drug: Digoxin |
| Period 2: Calderasib, Midazolam, and Digoxin | Experimental | A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first calderasib dosing in Period 2. Participants will receive calderasib once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11. Receives: Drug: Calderasib; Drug: Midazolam; Drug: Digoxin |
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 Midazolam
Blood samples will be collected to determine the AUC0-inf of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Midazolam
Blood samples will be collected to determine the AUC0-last of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of Midazolam
Blood samples will be collected to determine the AUC0-24hr of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Maximum Plasma Concentration (Cmax) of Midazolam
Blood samples will be collected to determine the Cmax of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Time to Maximum Plasma Concentration (Tmax) of Midazolam
Blood samples will be collected to determine the Tmax of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Apparent Terminal Half-life (t1/2) of Midazolam
Blood samples will be collected to determine the t1/2 of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Apparent Clearance (CL/F) of Midazolam
Blood samples will be collected to determine the CL/F of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Blood samples will be collected to determine the Vz/F of midazolam.
Measured: Predose and at designated timepoints up to 24 hours postdose
AUC0-Inf of Digoxin
Blood samples will be collected to determine the AUC0-inf of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
AUC0-Last of Digoxin
Blood samples will be collected to determine the AUC0-last of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
AUC0-24hr of Digoxin
Blood samples will be collected to determine the AUC0-24hr of digoxin.
Measured: Predose and at designated timepoints up to 24 hours postdose
Cmax of Digoxin
Blood samples will be collected to determine the Cmax of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
Tmax of Digoxin
Blood samples will be collected to determine the Tmax of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
t1/2 of Digoxin
Blood samples will be collected to determine the t1/2 of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
CL/F of Digoxin
Blood samples will be collected to determine the CL/F of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
Vz/F of Digoxin
Blood samples will be collected to determine the Vz/F of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
Secondary outcomes (13)
AUC0-24hr of Calderasib
Blood samples will be collected to determine the AUC0-24hr of calderasib.
Measured: Predose and at designated timepoints up to 24 hours postdose
AUC0-Last of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib.
Measured: Predose and at designated timepoints up to 24 hours postdose
Cmax of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: Predose and at designated timepoints up to 24 hours postdose
C24 of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Measured: Predose and at designated timepoints up to 24 hours postdose
Tmax of Calderasib
Blood samples will be collected to determine the Tmax of calderasib.
Measured: Predose and at designated timepoints up to 24 hours postdose
t1/2 of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib.
Measured: Predose and at designated timepoints up to 24 hours postdose
Cmax Accumulation Ratio of Calderasib
Blood samples will be collected to determine the Cmax accumulation ratio of calderasib. The accumulation ratio is the ratio of Predose Cmax to the 24 hour Cmax
Measured: Predose and at designated timepoints up to 24 hours postdose
AUC0-24 Accumulation Ratio of Calderasib
Blood samples will be collected to determine the AUC0-24 accumulation ratio of calderasib. The accumulation ratio is the ratio of Predose AUC0-24 to the 24 hour AUC0-24.
Measured: Predose and at designated timepoints up to 24 hours postdose
Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin
Urine samples will be collected to determine the Aet1-t2 of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
Total Amount of Drug Excreted in Urine (Ae) of Digoxin
Urine samples will be collected to determine the Ae of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
Fraction of Unchanged Digoxin in Urine (Fe)
Urine samples will be collected to determine the Fe of digoxin.
Measured: Predose and at designated timepoints up to 120 hours postdose
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 1 month
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start3 Sep 2024
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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
- NCT06575933
- Sponsor's protocol ID
- 1084-009
- Other IDs
- CA43815, MK-1084-009
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 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 Study to Evaluate the Effect of Single and Multiple Doses of MK-1084 on the Single-Dose Pharmacokinetics of Midazolam and Digoxin in Healthy Participants
- ClinicalTrials.gov ID
- NCT06575933
- Acronym / sponsor ID
- 1084-009
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 28 Aug 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 the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called calderasib. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without calderasib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Midazolam and Digoxin | Experimental | Drug: Midazolam, Drug: DigoxinParticipants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1. |
| Period 2: Calderasib, Midazolam, and Digoxin | Experimental | Drug: Calderasib, Drug: Midazolam, Drug: DigoxinA washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first calderasib dosing in Period 2. Participants will receive calderasib once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ECGs)
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
- Has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
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 administration | Drug | Period 2: Calderasib, Midazolam, and Digoxin |
| MidazolamOral administration | Drug | Period 1: Midazolam and Digoxin, Period 2: Calderasib, Midazolam, and Digoxin |
| DigoxinOral administration | Drug | Period 1: Midazolam and Digoxin, Period 2: Calderasib, Midazolam, and Digoxin |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-inf of midazolam.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-last of midazolam.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24hr of midazolam.
Maximum Plasma Concentration (Cmax) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the Cmax of midazolam.
Time to Maximum Plasma Concentration (Tmax) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the Tmax of midazolam.
Apparent Terminal Half-life (t1/2) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the t1/2 of midazolam.
Apparent Clearance (CL/F) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the CL/F of midazolam.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the Vz/F of midazolam.
AUC0-Inf of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the AUC0-inf of digoxin.
AUC0-Last of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the AUC0-last of digoxin.
AUC0-24hr of Digoxin
Time frame: Predose and at designated timepoints up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24hr of digoxin.
Cmax of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the Cmax of digoxin.
Tmax of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the Tmax of digoxin.
t1/2 of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the t1/2 of digoxin.
CL/F of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the CL/F of digoxin.
Vz/F of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Blood samples will be collected to determine the Vz/F of digoxin.
13 secondary outcomes
AUC0-24hr of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
AUC0-Last of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
Cmax of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
C24 of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
Tmax of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
t1/2 of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
Cmax Accumulation Ratio of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
AUC0-24 Accumulation Ratio of Calderasib
Time frame: Predose and at designated timepoints up to 24 hours postdose
Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Total Amount of Drug Excreted in Urine (Ae) of Digoxin
Time frame: Predose and at designated timepoints up to 120 hours postdose
Fraction of Unchanged Digoxin in Urine (Fe)
Time frame: Predose and at designated timepoints up to 120 hours postdose
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 1 month
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 1 month
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, Midazolam and Digoxin in people with Non-small Cell Lung Cancer, 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 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 (AUC0-Inf) of Midazolam (time frame: Predose and at designated timepoints up to 24 hours postdose). The study lists 16 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.