MK-7762 Safety and Tolerability Study

Overseen By Gates MRI

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bill & Melinda Gates Medical Research Institute

Must not be taking: Prescription medications

Disqualifiers: Cardiovascular, Neurologic, Drug abuse, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new drug, MK-7762 (also known as TBD09), in healthy individuals, marking its first use in humans. Researchers seek to understand how the body absorbs the drug both alone and with food. Non-smoking individuals with normal heart function and no significant medical history might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications, vitamins, dietary supplements, or herbal products at least 14 days before the trial starts.

Is there any evidence suggesting that MK-7762 (TBD09) is likely to be safe for humans?

Research shows that MK-7762 (TBD09) is being tested for safety and tolerability in humans. Scientists are examining how people react to the drug and identifying any side effects. As this is the first human trial, no previous data exists on its effects in people. In this early-stage trial, the primary focus is on safety to ensure the drug is generally well-tolerated before advancing to later stages.

Researchers closely monitor participants to quickly identify any side effects or issues. Since this is the initial human trial, no specific information from earlier studies is available. This careful approach helps ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MK-7762 is unique because it explores a potentially new mechanism of action that could differentiate it from existing treatments, though the specific condition it targets isn't explicitly mentioned. Researchers are particularly interested in how MK-7762 is tested in escalating doses and its interaction with food, which could influence its effectiveness and tolerability. Unlike other treatments that may have more rigid dosing, MK-7762's flexible dosing and consideration of food effects offer a novel approach that could lead to improved patient outcomes.

What evidence suggests that MK-7762 could be effective?

Research shows that MK-7762 (TBD09) is a new drug tested in this trial to assess its safety and how the body processes it. Participants will receive either MK-7762 or a placebo. Currently, little is known about its effectiveness because it remains in the early testing stages with healthy volunteers. The trial primarily aims to understand how the drug is absorbed and tolerated by the body. As this is the first human test, ensuring safety is the main goal before proceeding to further tests. However, the drug's mechanism suggests it might help treat certain conditions once its safety is confirmed. ^{1 2 3 4 6}

Who Is on the Research Team?

Gates MRI

Principal Investigator

Gates MRI

Are You a Good Fit for This Trial?

Healthy adults aged 19-55, non-smokers for at least 6 months, with a BMI of 18-32 and weight over 50 kg. Participants must have normal vital signs, no history of significant diseases or drug abuse, not be on certain medications or supplements recently, and women must be non-childbearing. Men engaging in sexual activity with women who can bear children must agree to use condoms.

Inclusion Criteria

Can complete all screening period evaluations and stay in the clinical research facility

I understand the trial's procedures and risks and can give informed consent.

Healthy as determined by medical history and clinical examination

Exclusion Criteria

I haven't had any cancer except for skin cancer in the last 5 years.

I don't have conditions affecting drug absorption or removal.

I am not allergic to the drugs used in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of MK-7762 to evaluate safety, tolerability, and pharmacokinetics

8-16 days

Participants remain at the trial site from Day -1 until their end-of-trial visit

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of MK-7762 over 28 days to evaluate safety, tolerability, and pharmacokinetics

28 days

Regular visits for PK measurements and safety assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-7762 (TBD09)
• Placebo

Trial Overview The trial is testing MK-7762 (TBD09), a new medication for tuberculosis. It involves giving healthy volunteers either the actual drug or a placebo to check its safety and how the body processes it. The study will also look into how food affects the absorption of this single oral dose.

How Is the Trial Designed?

Group I: MK-7762 (TBD09) Experimental Treatment 1 Intervention

In Part 1 of the trial (SAD/FE), up to five sequential cohorts will be enrolled to evaluate up to five escalating single doses of MK-7762; 8 participants in each cohort will be randomized (3:1) to receive MK-7762 or placebo. A sixth cohort will evaluate the effect of food on PK of single doses of MK-7762 utilizing an open-label, two-period design in 8 participants.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebos matched to MK-7762 (TBD09).

Who Is Running the Clinical Trial?

Bill & Melinda Gates Medical Research Institute

Lead Sponsor

Trials

15

Recruited

30,900+

Gates Medical Research Institute

Lead Sponsor

Merck Sharp & Dohme LLC

Industry 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/NCT05824091

Safety, Tolerability, Pharmacokinetics (PK), and Food Effect ... The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy ...

2. newtbdrugs.org newtbdrugs.org/pipeline/compound/tbd09-mk7762

TBD09 (MK7762) | Working Group for New TB Drugs The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07094932

NCT07094932 | A Study to Evaluate the Safety, Tolerability ... This is a randomized, double-blind, placebo-controlled, multiple dose trial of TBD09, administered to healthy adult participants to assess safety, ...

4. ctv.veeva.com ctv.veeva.com/study/safety-tolerability-pharmacokinetics-pk-and-food-effect-of-mk-7762-in-healthy-adults

Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of ... The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 ...

5. withpower.com withpower.com/trial/phase-1-tuberculosis-1-2023-8f2cb

MK-7762 Safety and Tolerability Study · Info for Participants This trial tests a new drug, MK-7762 (TBD09), on healthy volunteers to see if it is safe and how it is processed by the body. Researchers will also check if ...

6. guidetopharmacology.org guidetopharmacology.org/GRAC/LigandDisplayForward?tab=clinical&ligandId=13542

MK-7762 | Ligand page A first-in-human Phase 1 clinical trial, to assess the safety, tolerability, and pharmacokinetics of MK-7762 in healthy volunteers (NCT05824091), has been ...