Clinical trial NCT06619314: A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on MK-1084 in Healthy Adult Participants (MK-1084-003)
Official title: A Three-Part Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor 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: 2024-10-01
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of MK-1084 in a person's body over time.


Eligibility criteria: Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
* Medically healthy with no clinically significant medical history.

Exclusion Criteria:

* Has a history of cancer.
* Has had major surgery and/or donated or lost significant volume of blood.

Primary outcomes:
measure: Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: Maximum Plasma Concentration (Cmax) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: AUC0-inf of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1084
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Formulation Effect: Cmax of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Plasma Concentration at 24 hours (C24) of MK-1084
timeFrame: 24 hours postdose
measure: Formulation Effect: Lag Time (tlag) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Apparent Terminal Half-Life (t1/2) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Apparent Clearance (CL/F) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Proton Pump Inhibitor (PPI) Effect: AUC0-inf of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: Cmax of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
Secondary outcomes:
measure: Food Effect: AUC0-last of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: AUC0-24 of MK-1084
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: Food Effect: C24 of MK-1084
timeFrame: 24 hours postdose
measure: Food Effect: tlag of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: Tmax of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: t1/2 of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: CL/F of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: Vz/F of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 2 months
measure: Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
timeFrame: Up to approximately 2 months
measure: Formulation Effect: Number of Participants Who Experience a TEAE
timeFrame: Up to approximately 2 months
measure: Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
timeFrame: Up to approximately 2 months
measure: PPI Effect: AUC0-last of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: AUC0-24 of MK-1084
timeFrame: At designated timepoints (up to 24 hours postdose)
measure: PPI Effect: C24 of MK-1084
timeFrame: 24 hours postdose
measure: PPI Effect: tlag of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: Tmax of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: t1/2 of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: CL/F of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: Vz/F of MK-1084
timeFrame: At designated timepoints (up to 48 hours postdose)
measure: PPI Effect: Number of Participants Who Experience a TEAE
timeFrame: Up to approximately 2 months
measure: PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE
timeFrame: Up to approximately 2 months
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: