A Phase 1 interventional study of Calderasib and Midazolam in Non-small Cell Lung Cancer, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 28 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1.
Drug: Midazolam · Drug: Digoxin
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.
Drug: Calderasib · Drug: Midazolam · Drug: Digoxin
Oral administration
Also known as: MK-1084
Oral administration
Oral administration
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated timepoints up to 24 hours postdose
Cmax of Digoxin
Blood samples will be collected to determine the Cmax of digoxin.
Time frame: Predose and at designated timepoints up to 120 hours postdose
Tmax of Digoxin
Blood samples will be collected to determine the Tmax of digoxin.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated timepoints up to 120 hours postdose
AUC0-24hr of Calderasib
Blood samples will be collected to determine the AUC0-24hr of calderasib.
Time frame: 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.
Time frame: Predose and at designated timepoints up to 24 hours postdose
Cmax of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Time frame: Predose and at designated timepoints up to 24 hours postdose
C24 of Calderasib
Blood samples will be collected to determine the Cmax of calderasib.
Time frame: Predose and at designated timepoints up to 24 hours postdose
Tmax of Calderasib
Blood samples will be collected to determine the Tmax of calderasib.
Time frame: 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.
Time frame: 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
Time frame: 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.
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
Urine samples will be collected to determine the 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
Urine samples will be collected to determine the Ae of digoxin.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 1 month
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Merck Sharp & Dohme LLC