A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.
The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Be in good health
Has a body mass index (BMI) between 18 and 32 kg/m², inclusive
Disqualifiers
Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m²
Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
Has a history of cancer (malignancy)
Trial design
Design model
Crossover
Treatments tested in this trial
MK-8527
DrugOral tablet
Probenecid
DrugOral tablet
Itraconazole
DrugOral solution
Treatment groups
44 Participants
are divided into 3 treatment groupsGroup A: Part 1: MK-8527Experimental treatment 1 intervention
Group B: Part 2: MK-8527 + ProbenecidExperimental treatment 2 interventions
Group C: Part 3: MK-8527 + ItraconazoleExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)2
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)3
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)Secondary outcomes
1
Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)2
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)3
Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)4
Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
Time frame
Predose and at designated timepoints (up to 336 hours postdose)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov