A Phase 1 interventional study of MK-4318 and Diltiazem in Healthy and Pain, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
The goal of this study is to learn what happens to MK-4318 in a person's body over time. Researchers will compare what happens to levels of MK-4318 in people's blood when it is taken with and without diltiazem. Researchers also want to learn about the safety of MK-4318 taken with and without diltiazem and if people tolerate them.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
Participants will move sequentially through 2 Periods. In Period 1, participants receive MK-4318 orally. In Period 2, participants receive MK-4318 orally plus diltiazem orally.
Drug: MK-4318 · Drug: Diltiazem
Oral administration
Oral administration
Also known as: Cardizem®, Cartia XT®, Matzim LA®
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318
Blood samples will be collected to determine the AUC0-inf of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 4 days postdose)
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318
Blood samples will be collected to determine the AUC0-24hrs of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 1 day postdose)
Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs)
Blood samples will be collected to determine the C12hrs of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 12 hours postdose)
Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs)
Blood samples will be collected to determine the C24hrs of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 1 day postdose)
Maximum Plasma Concentration (Cmax) of MK-4318
Blood samples will be collected to determine the Cmax of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 4 days postdose)
Time to Maximum Plasma Concentration (Tmax) of MK-4318
Blood samples will be collected to determine the Tmax of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 4 days postdose)
Apparent Clearance (CL/F) of MK-4318
Blood samples will be collected to determine the CL/F of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 4 days postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318
Blood samples will be collected to determine the Vz/F of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 4 days postdose)
Apparent Terminal Half-life (t1/2) of MK-4318
Blood samples will be collected to determine the t1/2 of MK-4318 in the presence of diltiazem.
Time frame: At designated timepoints (up to approximately 4 days postdose)
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 60 days
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 9 days
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Feb 2024 to primary completion in Apr 2024, 2 months.
Of 62 phase 1 interventional studies under Pain, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9. This study's 2 months is below that.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diltiazem