A Clinical Trial of MK-6916 With Midazolam and Rosuvastatin in Healthy Participants (MK-6916-012)
ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Researchers will compare the amount of midazolam and rosuvastatin in a participant's body over time when they are given with and without MK-6916.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health
Has a body mass index between 18 and 32 kg/m², inclusive
Disqualifiers
Has history of cancer (malignancy)
Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
Trial design
Design model
Single group
Treatments tested in this trial
Midazolam
DrugAdministered orally on Day 1 of Period 1 and on Days 2 and 14 of Period 2.
Rosuvastatin
DrugAdministered orally on Day 1 of Period 1 and Day 14 of Period 2.
MK-6916
DrugAdministered orally once every 12 hours on Days 1 through 18 in Period 2.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Midazolam + Rosuvastatin + MK-6916Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Period 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Time frame
Predose and at designated timepoints up to approximately 24 hours2
Period 2: AUC0-inf of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Time frame
Predose and at designated timepoints up to approximately Day 153
Period 1: AUC0-inf of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Time frame
Predose and at designated timepoints up to approximately 96 hours4
Period 2: AUC0-inf of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Time frame
Predose and at designated timepoints up to approximately Day 19Secondary outcomes
1
Period 1: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).
Time frame
Predose and at designated timepoints up to approximately 24 hours2
Period 2: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).
Time frame
Predose and at designated timepoints up to approximately Day 153
Period 1: Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.
Time frame
Predose and at designated timepoints up to approximately 24 hours4
Period 2: AUC0-last of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.
Time frame
Predose and at designated timepoints up to approximately Day 15Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: