What is the mechanism of action of this treatment?

Common treatments for Tuberculosis include isoniazid, rifampin, ethambutol, and pyrazinamide. Isoniazid inhibits the synthesis of mycolic acids, essential components of the bacterial cell wall. Rifampin inhibits RNA synthesis by binding to the bacterial RNA polymerase. Ethambutol interferes with cell wall formation by inhibiting arabinosyl transferases. Pyrazinamide disrupts membrane transport and energy production in the bacteria. Understanding these mechanisms is crucial for TB patients as it helps in selecting the right combination of drugs to effectively target the bacteria, minimize resistance, and ensure safety and efficacy, which is the focus of pharmacokinetics and safety evaluations like the MK-7762 trial.

What side effects are associated with this type of intervention?

The most common treatments for Tuberculosis (TB) include isoniazid, rifampin, ethambutol, and pyrazinamide. Isoniazid can cause liver toxicity and peripheral neuropathy. Rifampin may lead to liver toxicity, gastrointestinal disturbances, and a red-orange discoloration of bodily fluids. Ethambutol can cause optic neuritis, leading to visual disturbances. Pyrazinamide is associated with liver toxicity and hyperuricemia, which can result in gout. These side effects are important considerations in the management of TB treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Tuberculosis, including first-line medications such as isoniazid, rifampin, ethambutol, and pyrazinamide. These drugs are typically used in combination to effectively treat TB and prevent resistance. Second-line treatments include fluoroquinolones and injectable agents like amikacin and capreomycin, used for drug-resistant TB. The study of MK-7762, focusing on pharmacokinetics and safety, is similar to the evaluations conducted for these TB drugs to ensure their efficacy and safety profiles before approval.

What other types of research exist?

Promising novel alternatives for tuberculosis treatment in 2024 include the use of rifapentine in place of rifampicin in the standard regimen, which has demonstrated a statistically safer profile for serious adverse events. Additionally, fluoroquinolones like levofloxacin and moxifloxacin are viable options if rifabutin cannot be used. These alternatives have shown efficacy and safety in clinical settings.

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MK-7762 Safety and Tolerability Study

Phase 1

Waitlist Available

Research Sponsored by Bill & Melinda Gates Medical Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 2, cohorts 1-3: day 1 through day 33.

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an initial test in humans (first-in-human study), potential side effects are being investigated but may include typical drug reactions such as nausea, headaches, allergic reactions or other unforeseen issues related to the medication's newness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 2, cohorts 1-3: day 1 through day 33.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 2, cohorts 1-3: day 1 through day 33.

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 2, cohorts 1-3: day 1 through day 33. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety: To characterize electrocardiogram (ECG) parameters after administration of single doses or multiple doses of MK-7762 (TBD09).

Safety: To characterize laboratory results after administration of single doses or multiple doses of MK-7762 (TBD09).

Safety: To characterize safety and tolerability of MK-7762 (TBD09) after administration of single doses or multiple doses in healthy adult participants.

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Secondary study objectives

Oral PK of MK-7762 (TBD09) following a single dose and multiple doses

Oral PK of MK-7762 (TBD09) following a single dose in a fasted state and fed state

Oral PK of MK-7762 (TBD09) following multiple doses

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Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-7762 (TBD09)Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-7762 (TBD09)

2023

Completed Phase 1

~120

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tuberculosis include isoniazid, rifampin, ethambutol, and pyrazinamide. Isoniazid inhibits the synthesis of mycolic acids, essential components of the bacterial cell wall. Rifampin inhibits RNA synthesis by binding to the bacterial RNA polymerase. Ethambutol interferes with cell wall formation by inhibiting arabinosyl transferases. Pyrazinamide disrupts membrane transport and energy production in the bacteria. Understanding these mechanisms is crucial for TB patients as it helps in selecting the right combination of drugs to effectively target the bacteria, minimize resistance, and ensure safety and efficacy, which is the focus of pharmacokinetics and safety evaluations like the MK-7762 trial.

Applicability of the shorter 'Bangladesh regimen' in high multidrug-resistant tuberculosis settings.