Clinical trial NCT06575933: A Study of MK-1084 With Midazolam and Digoxin in Healthy Participants (MK-1084-009)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hr) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Maximum Plasma Concentration (Cmax) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Time to Maximum Plasma Concentration (Tmax) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Apparent Terminal Half-life (t1/2) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Apparent Clearance (CL/F) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: AUC0-Inf of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: AUC0-Last of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: AUC0-24hr of Digoxin
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Cmax of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Tmax of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: t1/2 of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: CL/F of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Vz/F of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
Secondary outcomes:
measure: AUC0-24hr of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: AUC0-Last of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Cmax of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: C24 of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Tmax of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: t1/2 of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Cmax Accumulation Ratio of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: AUC0-24 Accumulation Ratio of MK-1084
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Amount of Drug Excreted in Urine from Time 1 to Time 2 (Aet1-t2) of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Total Amount of Drug Excreted in Urine (Ae) of Digoxin
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Fraction of Unchanged Digoxin in Urine (Fe)
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 1 month
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 1 month
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: