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)
- Registration Number
- NCT06619314
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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.
- Has a history of cancer.
- Has had major surgery and/or donated or lost significant volume of blood.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MK-1084 Treatment A MK-1084 Participants will receive MK-1084 on Day 1 on an empty stomach MK-1084 Treatment B MK-1084 Participants will receive MK-1084 on Day 1 after a high-fat/high-calorie breakfast MK-1084 Treatment C MK-1084 Participants will receive MK-1084 Formulation 1 on Day 1 MK-1084 Treatment D MK-1084 Participants will receive MK-1084 Formulation 2 on Day 1 MK-1084 Treatment E MK-1084 Participants will receive MK-1084 without a PPI on Day 1 MK-1084 Treatment F MK-1084 Participants will receive MK-1084 with a PPI on Day 5 MK-1084 Treatment F PPI Participants will receive MK-1084 with a PPI on Day 5
- Primary Outcome Measures
Name Time Method Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the AUC0-inf of MK-1084.
Food Effect: Maximum Plasma Concentration (Cmax) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Cmax of MK-1084.
Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the AUC0-last of MK-1084.
Formulation Effect: AUC0-inf of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the AUC0-inf of MK-1084.
Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1084 At designated timepoints (up to 24 hours postdose) Blood samples will be collected to determine the AUC0-24 of MK-1084.
Formulation Effect: Cmax of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Cmax of MK-1084.
Formulation Effect: Plasma Concentration at 24 hours (C24) of MK-1084 24 hours postdose Blood samples will be collected to determine the C24 of MK-1084.
Formulation Effect: Lag Time (tlag) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the tlag of MK-1084.
Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Tmax of MK-1084.
Formulation Effect: Apparent Terminal Half-Life (t1/2) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the t1/2 of MK-1084.
Formulation Effect: Apparent Clearance (CL/F) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the CL/F of MK-1084.
Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Vz/F of MK-1084.
Proton Pump Inhibitor (PPI) Effect: AUC0-inf of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the AUC0-inf of MK-1084.
PPI Effect: Cmax of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Cmax of MK-1084.
- Secondary Outcome Measures
Name Time Method Food Effect: AUC0-last of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the AUC0-last of MK-1084.
Food Effect: AUC0-24 of MK-1084 At designated timepoints (up to 24 hours postdose) Blood samples will be collected to determine the AUC0-24 of MK-1084.
Food Effect: C24 of MK-1084 24 hours postdose Blood samples will be collected to determine the C24 of MK-1084.
Food Effect: tlag of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the tlag of MK-1084.
Food Effect: Tmax of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Tmax of MK-1084.
Food Effect: t1/2 of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the t1/2 of MK-1084.
Food Effect: CL/F of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the CL/F of MK-1084.
Food Effect: Vz/F of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Vz/F of MK-1084.
Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE) Up to approximately 2 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE Up to approximately 2 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Formulation Effect: Number of Participants Who Experience a TEAE Up to approximately 2 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE Up to approximately 2 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
PPI Effect: AUC0-last of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the AUC0-last of MK-1084.
PPI Effect: AUC0-24 of MK-1084 At designated timepoints (up to 24 hours postdose) Blood samples will be collected to determine the AUC0-24 of MK-1084.
PPI Effect: C24 of MK-1084 24 hours postdose Blood samples will be collected to determine the C24 of MK-1084.
PPI Effect: tlag of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the tlag of MK-1084.
PPI Effect: Tmax of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Tmax of MK-1084.
PPI Effect: t1/2 of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the t1/2 of MK-1084.
PPI Effect: CL/F of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the CL/F of MK-1084.
PPI Effect: Vz/F of MK-1084 At designated timepoints (up to 48 hours postdose) Blood samples will be collected to determine the Vz/F of MK-1084.
PPI Effect: Number of Participants Who Experience a TEAE Up to approximately 2 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE Up to approximately 2 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Trial Locations
- Locations (1)
Celerion (Site 0001)
🇺🇸Lincoln, Nebraska, United States