MK-1708 for Healthy Subjects

No longer recruiting at 1 trial location

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Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, Cardiovascular, Neurological, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment called MK-1708 in healthy elderly individuals. Researchers seek to determine how well the body processes MK-1708 and whether the treatment remains in the blood for at least 24 hours. Participants will receive either one of two different doses of MK-1708 or a placebo (a substance with no active drug) for comparison. Ideal candidates for this trial are healthy individuals with a BMI between 18 and 32 and no major health issues in their medical history. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that MK-1708 is likely to be safe for humans?

Research has shown that MK-1708 is being tested for safety and tolerance, particularly in older adults. The main goal is to understand how individuals react to it and how the drug functions in their bodies over time. As an early-stage trial, it provides initial safety information, but detailed data on side effects may not yet be available.

In another study involving healthy Japanese participants, researchers examined MK-1708's safety and tolerance. They closely monitored for any side effects or reactions. These studies indicate a strong interest in ensuring the treatment's safety before further progression.

Currently, MK-1708 remains in the early testing phase, and researchers continue to collect crucial safety information. Prospective participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MK-1708 because it offers a potentially new way to treat conditions by using an innovative mechanism of action. Unlike many current treatments that mainly target symptoms, MK-1708 might work by directly addressing the underlying cause of the disease, potentially leading to more effective results. Another unique feature is its dosage flexibility, as the trial explores multiple doses, allowing researchers to fine-tune its effectiveness and safety. This could mean more personalized treatment options for patients in the future.

What evidence suggests that MK-1708 could be effective for healthy elderly subjects?

Researchers are investigating the safety and tolerability of MK-1708 in healthy older adults. Participants in this trial will receive either varying dosages of MK-1708 or a placebo. With limited information about MK-1708 in humans, scientists aim to understand its mechanism of action. They seek to determine if it maintains a certain blood level after 24 hours, which would suggest it might function as expected. Early results from similar studies have guided this research. However, there is not yet enough information to confirm its effectiveness for any specific health condition. ^{2 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This clinical trial is for healthy elderly individuals who have a body mass index (BMI) between 18 and 32 kg/m^2. Participants should be in good health before joining the study.

Inclusion Criteria

I am in good health overall.

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 multiple doses of MK-1708 or placebo to assess safety, tolerability, and pharmacokinetics

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-1708

Trial Overview The trial is testing MK-1708, a new medication, against a placebo to assess its safety and how well it's tolerated by elderly people. It also measures how MK-1708 behaves in the body over time.

How Is the Trial Designed?

Group I: MK-1708 Dosage 2 Experimental Treatment 1 Intervention

Participants receive multiple doses of MK-1708 dosage 2.

Group II: MK-1708 Dosage 1 Experimental Treatment 1 Intervention

Participants receive multiple doses of MK-1708 dosage 1.

Group III: Placebo Placebo Group 1 Intervention

Participants receive multiple doses of placebo.

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. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06647628/

A Clinical Study of MK-1708 in Healthy Elderly Participants The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06393374

NCT06393374 | Sacituzumab Tirumotecan (MK-2870) Plus ... This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab

3. merck.com merck.com/news/merck-announces-phase-3-trial-initiations-for-four-investigational-candidates-from-its-promising-hematology-and-oncology-pipeline/

Merck: Phase 3 Trials for 4 Hematology/Oncology Candidates No overall differences in safety or effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 ...

4. withpower.com withpower.com/clinical-trials/within-new-york-paid?page=5

Top Clinical Trials near New York | Power The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and ...

5. nature.com nature.com/articles/s41392-024-01760-0

New clinical trial design in precision medicine In clinical trial design, researchers should fully evaluate the sequencing data results and the biological implications of the enrolled patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06647628

A Clinical Study of MK-1708 in Healthy Elderly Participants ... Researchers will learn if at least 1 dose level of MK-1708 will be safe, well-tolerated, and will be above a certain level in people's blood after 24 hours.

7. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-10-2024-07c60

MK-1708 for Healthy Subjects · Info for Participants The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to ...

8. ctv.veeva.com ctv.veeva.com/study/single-and-multiple-dose-study-of-mk-1708-in-healthy-japanese-participants-mk1708004

Single and Multiple Dose Study of MK-1708 in Healthy ... This is a study of the safety, tolerability, and pharmacokinetics (PK) of MK-1708 in healthy Japanese participants.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06586606

A Study to Evaluate the Effects of Itraconazole on MK-1708 ... Also called a data safety and monitoring board, or DSMB. ... A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003).