Non-small Cell Lung Cancer
Conditions
Brief 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. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without calderasib.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of Midazolam | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the Tmax of midazolam. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam | 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 | 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 | 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 | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the Cmax of midazolam. |
| Apparent Terminal Half-life (t1/2) of Midazolam | 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 | 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 | 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 | 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 | 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 | 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 | Predose and at designated timepoints up to 120 hours postdose | Blood samples will be collected to determine the Cmax of digoxin. |
| Tmax of Digoxin | 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 | 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 | 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 | Predose and at designated timepoints up to 120 hours postdose | Blood samples will be collected to determine the Vz/F of digoxin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24hr of Calderasib | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the AUC0-24hr of calderasib. |
| AUC0-Last of Calderasib | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the AUC0-last of calderasib. |
| Cmax of Calderasib | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the Cmax of calderasib. |
| C24 of Calderasib | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the Cmax of calderasib. |
| Tmax of Calderasib | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the Tmax of calderasib. |
| t1/2 of Calderasib | Predose and at designated timepoints up to 24 hours postdose | Blood samples will be collected to determine the t1/2 of calderasib. |
| Cmax Accumulation Ratio of Calderasib | Predose and at designated timepoints up to 24 hours postdose | 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 |
| AUC0-24 Accumulation Ratio of Calderasib | Predose and at designated timepoints up to 24 hours postdose | 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. |
| Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin | Predose and at designated timepoints up to 120 hours postdose | Urine samples will be collected to determine the Aet1-t2 of digoxin. |
| Total Amount of Drug Excreted in Urine (Ae) of Digoxin | Predose and at designated timepoints up to 120 hours postdose | Urine samples will be collected to determine the Ae of digoxin. |
| Fraction of Unchanged Digoxin in Urine (Fe) | Predose and at designated timepoints up to 120 hours postdose | Urine samples will be collected to determine the Fe of digoxin. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 1 month | 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. |
| Number of Participants Who Discontinue Study Due to an AE | Up to approximately 1 month | 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. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed