Diltiazem + MK-6916 for Healthy Subjects

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, Cardiac arrhythmia, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 5 6 7 8}

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

My BMI is between 18 and 32.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-6916 and diltiazem orally to evaluate pharmacokinetics

8 weeks

Multiple visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: MK-6916 + Diltiazem Experimental Treatment 2 Interventions

Participants will receive MK-6916 and diltiazem orally.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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=10

A 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 ...

2. synapse.patsnap.com synapse.patsnap.com/target/9951a7a345d14ae4970e8e6f1b7c3c92

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.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36889610/

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 ...

5. withpower.com withpower.com/clinical-trials/near-madison-wi-paid?page=5

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 ...

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-1-2025-b134a

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.pdf

SAFETY 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-8e37-292703f16934

DILTIAZEM 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) ...