Clinical trial NCT06942741: A Study to Evaluate the Effect of Formulation and Food on MK-1084 in Healthy Adult Participants (MK-1084-011)
Official title: A Two-Part Study to Determine Bioequivalence Between the MK-1084 Film-Coated Tablet and Oral-Compressed Tablet and the Effect of Food on the Single-Dose Pharmacokinetics of the MK-1084 Film-Coated Tablet in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-04-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study has 2 parts. Researchers want to learn what happens to MK-1084 in a healthy person's body over time in both parts. The goals of the study are:

* In Part 1, to compare what happens to MK-1084 in a person's blood when it is taken as 2 different types of oral tablets
* In Part 2, to learn what happens to MK-1084 in a person's blood when it is taken on an empty stomach or after a meal


Eligibility criteria: Inclusion Criteria:

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

- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2

Exclusion Criteria:

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

* Has a history or presence of a clinically significant medical or psychiatric condition or disease
* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus

Primary outcomes:
measure: Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-1084
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Parts 1 and 2: Maximum Plasma Concentration (Cmax) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Parts 1 and 2: Plasma Concentration of MK-1084 at 24 Hours Postdose (C24)
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Parts 1 and 2: Apparent Terminal Half-life (t1/2) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Parts 1 and 2: Apparent Clearance (CL/F) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
measure: Part 2: Plasma Lag Time (tlag) of MK-1084
timeFrame: At designated timepoints (up to approximately 2 days postdose)
Secondary outcomes:
measure: Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 7 weeks
measure: Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 1 week
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: