A Clinical Study of MK-7262 and Enlicitide in Healthy Participants (MK-7262-003)
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorMerck Sharp & Dohme LLC
About this trial
The goal of this study is to learn what happens to a single dose of enlicitide over time in a healthy participant's body when the participant is given a single dose of MK-7262 and what happens to a single dose of MK-7262 over time in a healthy participant's body when the participant is given a single dose of enlicitide.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health before randomization
Has a body mass index (BMI) ≥18 and ≤32 kg/m², inclusive
Disqualifiers
Has a history or presence of clinically significant medical or psychiatric condition or disease
Has a history of cancer
Trial design
Design model
Crossover
Treatments tested in this trial
MK-7262
DrugOral administration
Enlicitide
DrugOral administration
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: MK-7262Experimental treatment 1 intervention
Group B: EnlicitideExperimental treatment 1 intervention
Group C: MK-7262 plus EnlicitideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-7262
Blood samples will be collected at multiple time points to estimate the AUC0-inf of MK-7262.
Time frame
Predose and at designated time points post-dose (up to 8 days)2
AUC0-inf of Enlicitide
Blood samples will be collected at multiple time points to estimate the AUC0-inf of enlicitide.
Time frame
Predose and at designated time points post-dose (up to 8 days post-dose)3
Maximum Plasma Concentration (Cmax) of MK-7262
Blood samples will be collected at multiple time points to estimate the steady-state Cmax of MK-7262.
Time frame
Predose and at designated time points post-dose (up to 8 days post-dose)4
Cmax of Enlicitide
Blood samples will be collected at multiple time points to estimate the steady-state Cmax of enlicitide.
Time frame
Predose and at designated time points post-dose (up to 8 days post-dose)Secondary outcomes
1
Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of MK-7262
Blood samples will be collected at multiple time points to estimate the AUC0-24 of MK-7262.
Time frame
Predose and at designated time points post-dose (up to 24 hours post-dose)2
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-7262
Blood samples will be collected at multiple time points to estimate the AUC0-last of MK-7262.
Time frame
Predose and at designated time points post-dose (up to 8 days post-dose)3
Time to Maximum Plasma Concentration (Tmax) of MK-7262
Blood samples will be collected at multiple time points to estimate the Tmax of MK-7262.
Time frame
Predose and at designated time points post-dose (up to 8 days post-dose)4
Apparent Terminal Half-life (t1/2) of MK-7262
Blood samples will be collected at multiple time points to estimate the t1/2 of MK-7262.
Time frame
Predose and at designated time points post-dose (up to 8 days post-dose)Sponsors and contacts
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Source ClinicalTrials.gov