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

119 Participants Needed

Trial Summary

What is the purpose of this trial?

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 food affects how the drug is absorbed.

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.

Research Team

Gates MRI

Principal Investigator

Gates MRI

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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