A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06575933
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Period 2: MK-1084, Midazolam, and Digoxin Midazolam A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first MK-1084 dosing in Period 2. Participants will receive MK-1084 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. Period 2: MK-1084, Midazolam, and Digoxin MK-1084 A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first MK-1084 dosing in Period 2. Participants will receive MK-1084 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. Period 1: Midazolam and Digoxin Midazolam Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1. Period 1: Midazolam and Digoxin Digoxin Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1. Period 2: MK-1084, Midazolam, and Digoxin Digoxin A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first MK-1084 dosing in Period 2. Participants will receive MK-1084 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
Cmax of Digoxin Predose and at designated timepoints up to 120 hours postdose Blood samples will be collected to determine the Cmax 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.
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.
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.
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.
Tmax of Digoxin Predose and at designated timepoints up to 120 hours postdose Blood samples will be collected to determine the Tmax of digoxin.
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.
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-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.
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.
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.
- Secondary Outcome Measures
Name Time Method Cmax Accumulation Ratio of MK-1084 Predose and at designated timepoints up to 24 hours postdose 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
AUC0-24 Accumulation Ratio of MK-1084 Predose and at designated timepoints up to 24 hours postdose 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.
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.
AUC0-24hr of MK-1084 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the AUC0-24hr of MK-1084.
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 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.
AUC0-Last of MK-1084 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the AUC0-last of MK-1084.
Cmax of MK-1084 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the Cmax of MK-1084.
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.
C24 of MK-1084 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the Cmax of MK-1084.
Tmax of MK-1084 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the Tmax of MK-1084.
t1/2 of MK-1084 Predose and at designated timepoints up to 24 hours postdose Blood samples will be collected to determine the t1/2 of MK-1084.
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.
Trial Locations
- Locations (1)
Celerion ( Site 0001)
🇺🇸Tempe, Arizona, United States