A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005)
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 weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine.
The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken without (Period 1) and with (Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 taken with and without diltiazem and if people tolerate them.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health
Body mass index (BMI) between 18 and 32 kg/m², inclusive
Disqualifiers
Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
Had a recent pancreatitis or has a history of pancreatitis
Trial design
Design model
Sequential
Treatments tested in this trial
MK-4082
DrugOral administration
Diltiazem
DrugOral administration
Rescue medication
DrugAll participants will receive ondansetron as a rescue medication. Ondansetron is a medication used to prevent nausea or vomiting.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: MK-4082 + DiltiazemExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4082
Blood samples will be collected to determine the AUC0-inf of MK-4082.
Time frame
At designated timepoints (up to approximately 1 week postdose)2
Maximum Plasma Concentration (Cmax) of MK-4082
Blood samples will be collected to determine the Cmax of MK-4082.
Time frame
At designated timepoints (up to approximately 1 week postdose)3
Number of Participants Who Experience an Adverse Event (AE)
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. The number of participants who experience an AE will be reported.
Time frame
Up to approximately 31 days4
Number of Participants Who Discontinue Study Intervention Due to an AE
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. The number of participants who discontinue study intervention due to an AE will be reported.
Time frame
Up to approximately 17 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: