MK-1084 for Healthy Subjects

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Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 2

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-1084, behaves in the bodies of healthy individuals. In Part 1, researchers will compare the effects of two different tablet forms of MK-1084 taken on an empty stomach. In Part 2, they will study how taking the treatment with or without food affects drug levels in the blood. Individuals who are generally healthy, free from significant medical conditions, and have a body mass index between 18 and 32 may be suitable for this trial. 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 it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

Is there any evidence suggesting that MK-1084 is likely to be safe for humans?

Research has shown that MK-1084 generally has a manageable safety profile. In earlier studies, some patients experienced side effects, but these were usually manageable. About 98% of patients had at least one side effect, with only 35% being serious.

Overall, most participants tolerated MK-1084 well, whether taken alone or with other treatments. While side effects can occur, they are typically not severe and can be managed with proper care. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about MK-1084 because it offers a potentially innovative approach to treatment. Unlike other treatments that might use different active ingredients, MK-1084 is being explored in various forms, like film-coated and oral-compressed tablets, to see how they perform under different conditions such as fasting or after a high-fat meal. This could lead to more flexible dosing options that fit better with everyday life. Additionally, by testing both low and high doses, researchers are keen to understand the optimal conditions and dosing for maximum effectiveness, which could be a game-changer in its therapeutic area.

What evidence suggests that MK-1084 could be effective?

Research has shown that MK-1084 targets KRAS mutations, which are changes in a specific gene often found in cancers like colorectal and non-small cell lung cancer. These mutations appear in about 30% of human tumors. Early studies suggest that MK-1084 exhibits antitumor activity, potentially shrinking tumors or slowing their growth. Designed for oral administration, the treatment offers a more convenient option than other methods. Although the trial currently focuses on understanding how the body processes MK-1084 in healthy subjects, initial findings are promising for its potential use in fighting certain types of cancer. ^{1 6 7 8 9}

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 adults with a body mass index (BMI) between 18.0 and 32.0 kg/m^2 who are interested in helping researchers understand how a new medication, MK-1084, behaves in the body.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Part 1 Treatment

Participants receive low dose MK-1084 as either a film-coated tablet or oral-compressed tablet under fasted conditions

1 day

1 visit (in-person)

Part 2 Treatment

Participants receive higher dose MK-1084 as a film-coated tablet under either fed or fasted conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-1084

Trial Overview The study tests two different oral tablet forms of MK-1084 to see how they affect blood levels over time. It also examines the impact of taking MK-1084 with or without food on its absorption and presence in the bloodstream.

How Is the Trial Designed?

Group I: Part 2 MK-1084 Treatment D Experimental Treatment 1 Intervention

Participants will be administered higher dose MK-1084 as a FCT on Day 1 under fed conditions (after a high-fat meal)

Group II: Part 2 MK-1084 Treatment C Experimental Treatment 1 Intervention

Participants will be administered higher dose MK-1084 as a FCT on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Group III: Part 1 MK-1084 Treatment B Experimental Treatment 1 Intervention

Participants will be administered low dose MK-1084 as a film-coated tablet (FCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

Group IV: Part 1 MK-1084 Treatment A Experimental Treatment 1 Intervention

Participants will be administered low dose MK-1084 as an oral-compressed tablet (OCT) on Day 1 under fasted conditions (on an empty stomach after a ≥8-hour fast)

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. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-effect-of-formulation-and-food-on-mk-1084-in-healthy-adult-participants-mk

A Study to Evaluate the Effect of Formulation and Food on MK ... This study has 2 parts. Researchers want to learn what happens to MK-1084 in a healthy person's body over time in both parts.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38924388/

Discovery of MK-1084: An Orally Bioavailable and Low- ... Oncogenic mutations in the RAS gene account for 30% of all human tumors; more than 60% of which present as KRAS mutations at the hotspot ...

3. merck.com merck.com/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/

Merck Announces MK-1084, an Investigational KRAS ... ... patients in the MK-1084 and cetuximab arm and 97% (n=32) of patients in the MK-1084 with cetuximab and mFOLFOX6 arm. These KANDLELIT-001 CRC and ...

4. fda.gov fda.gov/media/170783/download

Clinical Pharmacology Considerations for Food Effect ... Food can increase or decrease drug exposure, impacting safety/efficacy. Assessing food effects helps understand drug exposure and provide ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04449250

Fed-Fast Crossover Study to Assess the Effect of Food With ... This study assesses how food affects the absorption of CTx-1301 in healthy adults, comparing fed and fasted states.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05067283

NCT05067283 | A Study of MK-1084 in KRAS Mutant ... This is a study evaluating the safety, pharmacokinetics, and efficacy of MK-1084 alone, and MK-1084 plus other combination therapies in participants with ...

7. onclive.com onclive.com/view/mk-1084-alone-and-plus-pembrolizumab-shows-early-safety-activity-in-kras-g12c-solid-tumors

MK-1084 Alone and Plus Pembrolizumab Shows Early ... In arm 1, 98% of patients who received MK-1084 monotherapy at all doses (n = 55) experienced at least 1 AE; these effects were grade 3 for 35% ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02686-8/fulltext

663P Safety and preliminary efficacy of the KRAS G12C ... Conclusions. MK-1084 as monotherapy and in combination with pembro showed manageable safety and preliminary antitumor activity in pts with previously treated ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8605

MK-1084 for KRAS G12C-mutated (mut) metastatic non– ... MK-1084 shows manageable safety and antitumor activity as monotherapy for previously treated disease and in combination with pembro ± chemo as first-line (1L) ...