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MK-7762 Safety and Tolerability Study

Phase 1
Recruiting
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.
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of an oral medicine in healthy volunteers, and its absorption when taken with food.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
+1 more
Secondary outcome measures
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
+2 more

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).

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,961 Total Patients Enrolled
8 Trials studying Tuberculosis
3,078 Patients Enrolled for Tuberculosis
Bill & Melinda Gates Medical Research InstituteLead Sponsor
12 Previous Clinical Trials
32,103 Total Patients Enrolled
6 Trials studying Tuberculosis
30,845 Patients Enrolled for Tuberculosis
Gates MRIStudy DirectorGates MRI
8 Previous Clinical Trials
31,297 Total Patients Enrolled
6 Trials studying Tuberculosis
30,845 Patients Enrolled for Tuberculosis

Media Library

MK-7762 (TBD09) (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05824091 — Phase 1
Tuberculosis Research Study Groups: MK-7762 (TBD09), Placebo
Tuberculosis Clinical Trial 2023: MK-7762 (TBD09) Highlights & Side Effects. Trial Name: NCT05824091 — Phase 1
MK-7762 (TBD09) (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05824091 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more participants being accepted for this clinical investigation?

"Affirmative. According to records on clinicaltrials.gov, this medical research project is currently enrolling patients and was initially posted on February 23rd 2023 with its latest update occurring April 11th 2023. A total of 96 participants are required from one centre."

Answered by AI

What is the current enrollment capacity for this clinical trial?

"Indeed, information accessible through clinicaltrials.gov reiterates that this medical trial launched on February 23rd 2023 and is actively searching for 96 patients from 1 site. The study was last updated April 11th of the same year."

Answered by AI

What would be the desired outcome if this experiment is successful?

"During this clinical trial, which will span 33 days, the primary goal is to evaluate laboratory results in response to MK-7762 (TBD09). Secondary objectives include gauging oral bioavailability of the drug through measuring its Area under the Concentration Time Curve (AUCTau) and Accumulation Ratio (AUCTau/ AUC(0-24))."

Answered by AI

Who is eligible to be enrolled in this clinical study?

"For this medical experiment, 96 individuals between the ages of 19 and 55 that are currently suffering from tuberculosis must be recruited. Moreover, males who are not sterilized and sexually active with a female partner capable of bearing children need to commit to using contraceptives for 90 days post-treatment as well as abstaining from sperm donation during the trial's duration."

Answered by AI

Has FDA authorization been granted for MK-7762 (TBD09)?

"The safety of MK-7762 (TBD09) is inferred to be at a level 1, as this Phase 1 trial has only provided limited evidence concerning its efficacy and security."

Answered by AI

Are there any age restrictions for enrolling in this research trial?

"This experiment is searching for individuals who are between 19 and 55 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
2023. "Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824091.
~44 spots leftby Apr 2025
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