Clinical trial NCT06719557: A Study of the Effect of Itraconazole and Phenytoin on MK-1084 in Healthy Adults (MK-1084-008)
Official title: A Two-Part Study to Evaluate the Effects of Multiple Doses of Itraconazole and Multiple Doses of Phenytoin on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn what happens to MK-1084 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of MK-1084 when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.


Eligibility criteria: Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of cancer (malignancy)
* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Part 1 Only:

- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)

Pat 2 Only:

- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-1084
timeFrame: Pre-dose and at designated time points up to 24 hours post dose
measure: Maximum Plasma Concentration (Cmax) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
measure: Plasma Concentration at 24 Hours (C24) of MK-1084
timeFrame: Pre-dose and at designated time points up to 24 hours post dose
measure: Time to Maximum Plasma Concentration (Tmax) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
measure: Apparent Terminal Half-life (t1/2) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
measure: Apparent Clearance (CL/F) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of MK-1084
timeFrame: Pre-dose and at designated time points up to 72 hours post dose
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 41 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 25 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: