Diltiazem for Nemtabrutinib Levels in Healthy Subjects

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Endocrine, Cardiovascular, Neurological, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the drug nemtabrutinib behaves in the body when taken alone versus with diltiazem, a calcium channel blocker. Researchers seek to compare nemtabrutinib levels in healthy individuals over time. Participants will first take nemtabrutinib alone and then with diltiazem. The trial seeks healthy individuals with a BMI between 18.5 and 32 who have no history of serious health issues or cancer. 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 drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nemtabrutinib, the main treatment under study, has demonstrated promising safety results in early trials. Participants have generally tolerated it well, with no major safety concerns reported. In this study, nemtabrutinib combines with diltiazem, a drug that manages heart conditions by relaxing blood vessels. Although diltiazem is usually safe, it has occasionally been linked to serious heart issues, such as irregular heartbeats.

This trial aims to provide more information about the safety of using these drugs together. Based on current knowledge, nemtabrutinib alone has maintained a good safety record so far. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore how diltiazem affects the levels of nemtabrutinib in the body. Nemtabrutinib is a promising compound, and understanding its interactions with other drugs like diltiazem could optimize its effectiveness. Unlike typical approaches that focus solely on individual drug effects, this study aims to understand drug interactions, which could lead to more personalized and effective treatment regimens. This could pave the way for better management of conditions that nemtabrutinib targets, providing more tailored therapeutic options.

What evidence suggests that this trial's treatments could be effective?

Research has shown that nemtabrutinib, a type of drug, has promising results in treating certain blood cancers. Studies indicate it effectively fights cancer in both lab tests and early patient trials. By targeting specific proteins in cancer cells, it prevents them from growing. In this trial, participants will receive nemtabrutinib alone in one treatment arm and in combination with diltiazem in another arm. Understanding how nemtabrutinib works in the body, both alone and with diltiazem, is crucial for its development as a treatment. Overall, early results for nemtabrutinib are encouraging for its potential use in cancer treatment. ^{1 3 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 Body Mass Index (BMI) between 18.5 and 32 kg/m2. Participants should not have any known medical conditions that could interfere with the study.

Inclusion Criteria

I am in good health overall.

My BMI is between 18.5 and 32.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Period 1: Nemtabrutinib

Participants will receive nemtabrutinib followed by a protocol specified wash-out period

2 weeks

Period 2: Diltiazem + Nemtabrutinib

Participants will receive diltiazem plus nemtabrutinib

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Diltiazem
• Nemtabrutinib

Trial Overview The study is examining how nemtabrutinib levels change over time in the body when taken alone versus when combined with diltiazem, another medication.

How Is the Trial Designed?

Group I: Period 2: Diltiazem + Nemtabrutinib Experimental Treatment 2 Interventions

Participants will receive diltiazem plus nemtabrutinib.

Group II: Period 1: Nemtabrutinib Experimental Treatment 1 Intervention

Participants will receive nemtabrutinib followed by a protocol specified wash-out period.

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/NCT07232589

A Study of the Effect of Diltiazem on the Plasma Levels ... A Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants.

2. ctv.veeva.com ctv.veeva.com/study/a-study-of-the-effect-of-diltiazem-on-the-plasma-levels-of-nemtabrutinib-mk1026022

A Study of the Effect of Diltiazem on the Plasma Levels of ... The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time.

3. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-a-study-of-the-effect-of-diltiazem-on-the-plasma-levels-of-nemtabrutinib--mk-1026-022-/555772847

Clinical Trial: A Study of the Effect of Diltiazem on ... 14. Brief Summary: The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time.

4. synapse.patsnap.com synapse.patsnap.com/drug/266e1df0d79b4509959a0bf4f1cdc317

Nemtabrutinib - Drug Targets, Indications, Patents A Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants. NCT07194980.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7058763/

The pharmacokinetics of diltiazem in healthy American men After administration of 60 mg (n = 12), 90 mg (n = 10), and 120 mg (n = 4), peak plasma concentrations were 72, 117, and 152 ng/cm3 and time to peak ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548057/

PMC - PubMed Central Early-phase data with pirtobrutinib suggest an encouraging CV safety profile, potentially due to the high BTK selectivity and limited off-target ...

7. iwmf.com iwmf.com/wp-content/uploads/2025/10/s40256-025-00757-6.pdf

Cardiovascular Safety of Bruton Tyrosine Kinase Inhibitors Beta-blockers are preferred because of their safety profile and minimal drug interactions [79]. Cal- cium channel blockers such as verapamil and diltiazem, as.

8. drugs.com drugs.com/interactions-check.php?drug_list=3871-18696,890-0&professional=1

Drug Interaction Report: Calquence, diltiazem Diltiazem can cause ventricular fibrillation and cardiac arrest in such patients, the mechanism of which is related to the drug's ability to shorten the ...