A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
NCT Number: NCT06575933
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non-small Cell Lung Cancer
Interventions: DRUG: MK-1084|DRUG: Midazolam|DRUG: Digoxin
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT
Enrollment: 28
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-05
Completion Date: 2024-10-28

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 MK-1084. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without MK-1084.

Primary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., Predose and at designated timepoints up to 24 hours postdose|Cmax of Digoxin, Blood samples will be collected to determine the Cmax of digoxin., Predose and at designated timepoints up to 120 hours postdose|Tmax of Digoxin, Blood samples will be collected to determine the Tmax of digoxin., 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., 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., 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., Predose and at designated timepoints up to 120 hours postdose
Secondary Outcome Measures: AUC0-24hr of MK-1084, Blood samples will be collected to determine the AUC0-24hr of MK-1084., Predose and at designated timepoints up to 24 hours postdose|AUC0-Last of MK-1084, Blood samples will be collected to determine the AUC0-last of MK-1084., Predose and at designated timepoints up to 24 hours postdose|Cmax of MK-1084, Blood samples will be collected to determine the Cmax of MK-1084., Predose and at designated timepoints up to 24 hours postdose|C24 of MK-1084, Blood samples will be collected to determine the Cmax of MK-1084., Predose and at designated timepoints up to 24 hours postdose|Tmax of MK-1084, Blood samples will be collected to determine the Tmax of MK-1084., Predose and at designated timepoints up to 24 hours postdose|t1/2 of MK-1084, Blood samples will be collected to determine the t1/2 of MK-1084., Predose and at designated timepoints up to 24 hours postdose|Cmax Accumulation Ratio of MK-1084, Blood samples will be collected to determine the Cmax accumulation ratio of MK-1084. The accumulation ratio is the ratio of Predose Cmax to the 24 hour Cmax, Predose and at designated timepoints up to 24 hours postdose|AUC0-24 Accumulation Ratio of MK-1084, Blood samples will be collected to determine the AUC0-24 accumulation ratio of MK-1084. The accumulation ratio is the ratio of Predose AUC0-24 to the 24 hour AUC0-24., 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., 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., 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., 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., 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., Up to approximately 1 month