Diltiazem + MK-6916 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how a new treatment, MK-6916, behaves in the bodies of healthy individuals. Researchers seek to determine MK-6916 levels when taken alone and when combined with diltiazem. The trial is designed for generally healthy individuals with a body mass index (BMI) between 18 and 32, without major health issues in areas such as the heart, liver, or immune system. Participants will help researchers learn how these medications interact, which is crucial for future treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
In a previous study, researchers examined how the body processes MK-6916 when taken with diltiazem. Healthy participants tolerated both drugs well, and no serious side effects were reported for MK-6916. Diltiazem, commonly used for heart problems, has known side effects, but they are usually mild and manageable, such as dizziness or fatigue.
As this is a Phase 1 trial, researchers primarily focus on assessing the drug's safety and how the body handles it. Current data suggest that the combination of MK-6916 and diltiazem is safe for healthy individuals.12345Why are researchers excited about this trial's treatments?
MK-6916 is unique because it combines with diltiazem to potentially offer a new approach to treatment. While most treatments in this category focus on single agents, this combination targets different mechanisms, which may enhance efficacy or reduce side effects. Researchers are excited about exploring how these two drugs together can improve outcomes, offering hope for a more effective solution.
What evidence suggests that this trial's treatments could be effective?
Research has shown that taking MK-6916 orally can reduce LDL cholesterol (often called "bad" cholesterol) by up to 60%. This reduction was observed in studies where participants took either 30 mg or 18 mg daily. The results were statistically significant, indicating they were unlikely due to chance. In this trial, participants will receive a combination of MK-6916 and diltiazem to examine how this combination affects MK-6916 levels in the body. Although this study does not focus on treating a specific condition, the cholesterol-lowering potential of MK-6916 is promising.15678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for healthy individuals with a BMI between 18 to 32 kg/m^2. The study aims to understand how the body processes MK-6916, both alone and when taken with another drug called diltiazem.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MK-6916 and diltiazem orally to evaluate pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Diltiazem
- MK-6916
Trial Overview
The study is testing the effects of multiple doses of Diltiazem on plasma levels of a drug called MK-6916 in healthy participants. It will compare the changes in MK-6916 levels when administered alone versus alongside Diltiazem.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive MK-6916 and diltiazem orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06818968?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(DILTIAZEM%20MALATE))&rank=10A Study of the Effect of Multiple Doses of Diltiazem on ...
The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 in ...
Cav2.2 - Drugs, Indications, Patents
Effectiveness of 2 percent diltiazem topical ointment versus partial ... Diltiazem on the Single-dose Pharmacokinetics of MK-6916 in Healthy Participants.
Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor ...
MK-0616 demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to 60.9% from ...
4.
blogs.bcm.edu
blogs.bcm.edu/2023/03/14/from-the-labs-clinical-trial-finds-that-oral-drug-mk-0616-substantially-reduces-bad-cholesterol/Clinical trial finds that oral drug MK-0616 substantially ...
Results from this phase II trial showed MK-0616 reduced LDL-cholesterol by around 60% among people taking 30 mg or 18 mg daily, compared to those taking a ...
Top Clinical Trials near Madison, WI | Power
Diltiazem + MK-6916 for Healthy Subjects. Madison, Wisconsin. The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body ...
Diltiazem + MK-6916 for Healthy Subjects
This trial is for healthy individuals with a BMI between 18 to 32 kg/m^2. The study aims to understand how the body processes MK-6916, both alone and when taken ...
7.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9TEVA_DILTIAZEM_TAB_30MG_100BT_9TEVA.pdfSAFETY DATA SHEET
Toxic solid, organic, n.o.s (Diltiazem Hydrochloride). 14.3. Transport hazard class(es). Land transport (ADR/RID). 6.1. Sea transport (IMDG).
8.
dailymed.nlm.nih.gov
dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=04a85be5-f746-418e-8e37-292703f16934DILTIAZEM HYDROCHLORIDE capsule, extended release
Diltiazem hydrochloride is contraindicated in: (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker; (2) ...
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