Completed

Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MK-7762 (TBD09)

+ Placebo
Drug
Other
Who is being recruted

Tuberculosis

From 19 to 55 Years
+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 1
Interventional
Study Start: February 2023

See protocol details

Summary

Principal SponsorBill & Melinda Gates Medical Research Institute
Last updated: July 26, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: February 23, 2023Actual date on which the first participant was enrolled.

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 volunteers in the context of a first-in-human study. The effect of food on the rate and extent of absorption of a single oral dose of MK-7762 (TBD09) will also be evaluated. This is a 2-part blinded, placebo-controlled, combined single ascending dose with a food effect cohort and multiple ascending dose trial to be conducted in one trial center in the United States. Part 1 has a single ascending dose (SAD) design with up to 5 planned dose levels. Based on the interim PK results reviewed for the dose escalation decisions, a dose will be selected for administration to a sixth cohort both in fed and fasted states to evaluate the effect of food on MK-7762 (TBD09). Safety will be assessed throughout the study; cardiac monitoring/serial ECGs and serial blood samples will be collected for the safety and PK assessment of MK7762 (TBD09). Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor, in conjunction with the Principal Investigator, has determined that adequate safety, tolerability (and PK for the later cohorts) from the previous cohort has been demonstrated to permit proceeding to the next cohort. Interim PK analyses will be performed for the dose escalation decisions (after cohorts 1 and 2 are completed), to select the intermediate dose for the food effect cohort, and to reconsider the sampling time points as the trial progresses. All samples will be sent for analysis and the bioanalytical lab will be unblinded and only run the analysis on active treatment participants. At the escalation meetings, PK analyses from active treatment participants and blinded (pooled) safety summaries will be reviewed. All participants in Part 1 will remain at the trial site from Day -1 until their end of-trial visit (approximately 8 days for Cohorts 1-5 and 16 days for Cohort 6). At the end of Part 1, pharmacokinetic and unblinded safety data along with dose rationale for Part 2 will be sent to the Food and Drug Administration (FDA) for review and approval. The trial will not proceed to Part 2 until the FDA provides approval. Part 2 has a multiple ascending dose (MAD) design. The dose cohorts for Part 2 will be determined based on model predictions to determine the steady-state Cmax exposure, and safety from Part 1. In this MAD part, each participant will be administered MK7762 or matching placebo for 28 days with corresponding PK measurements. Three dose cohorts are planned. After each dose cohort, the Sponsor and Investigator will review the PK and safety data before proceeding to the next dose level.

Official TitleA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Trial in Healthy Adults to Evaluate the Safety, Tolerability, and PK of MK-7762 
Principal SponsorBill & Melinda Gates Medical Research Institute
Last updated: July 26, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
119 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 19 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Tuberculosis
Criteria
15 inclusion criteria required to participate
o be included in this trial, an individual must satisfy all the following criteria
Is ≥ 19 to ≤ 55 years of age
Is healthy as determined by the Investigator via medical history and clinical examination before enrollment in the trial
Can understand and comply with the trial and site procedures, understand the risks involved in the trial, and provide written informed consent before the first trial-specific procedure

Show More Criteria

15 exclusion criteria prevent from participating
f an individual meets any of the following criteria, they are ineligible for this trial
Has current or past history of a clinically significant cardiovascular, cerebrovascular, respiratory, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, as determined by the Investigator
Has history of or Screening findings of abnormalities of vision, including corrected visual acuity worse than 20/25 in either eye based on Screening assessment using Snellen chart and Rosenbaum pocket chart, or color vision impairment based on Screening assessment using Ishihara plates. Candidates with ametropia corrected to 20/25 or better do not have to be excluded
Has history of or Screening findings of peripheral neuropathy, such as numbness or abnormal reflexes

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
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
Participants will receive placebos matched to MK-7762 (TBD09).
Study Objectives
Primary Objectives

Assessed by the proportion of treated participants reporting treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), assessed overall, by severity, by relationship to study drug, and by system organ class and preferred term.

Assessed by the proportion of treated participants reporting treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), assessed overall, by severity, by relationship to study drug, and by system organ class and preferred term.

Assessed by the proportion of treated participants reporting treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), assessed overall, by severity, by relationship to study drug, and by system organ class and preferred term.

In treated participants, summaries (descriptive statistics and frequencies) of safety laboratory measures (by visit, worst grade, grade shift from baseline) according to the same windows defined above for AEs.

In treated participants, summaries (descriptive statistics and frequencies) of safety laboratory measures (by visit, worst grade, grade shift from baseline) according to the same windows defined above for AEs.

In treated participants, 12-lead ECG parameters including ECG QT interval with correction factors, heart rate, RR interval, PR interval (by visit, change from baseline) according to the same windows defined above for AEs.

In treated participants, 12-lead ECG parameters including ECG QT interval with correction factors, heart rate, RR interval, PR interval (by visit, change from baseline) according to the same windows defined above for AEs.

In treated participants, vital signs (by visit, change from baseline) according to the same windows defined above for AEs.

In treated participants, vital signs (by visit, change from baseline) according to the same windows defined above for AEs.
Secondary Objectives

Maximum plasma drug concentration (Cmax)

Time to maximum plasma drug concentration (Tmax)

Area under the concentration-time curve (AUC) calculated over the first 24h (AUC(0-24)

AUC calculated over a dosing interval (AUCTau)

AUC calculated to last quantifiable observed sample (AUC(0-last))

AUC calculated to last quantifiable observed sample (AUC(0-last))

AUC extrapolated to infinity (AUC(0-inf))

AUC extrapolated to infinity (AUC(0-inf))

Terminal elimination half-life (t½)

Terminal elimination half-life (t½)

Oral clearance (CL/F)

Oral clearance (CL/F)

Oral volume of distribution (Vd/F)

Oral volume of distribution (Vd/F)

Accumulation ratio (AUCTau / AUC(0-24))

AUC(0-inf) fasted state / AUC(0-inf) fed state

Cmax fasted state / Cmax fed state

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Investigational SiteLincoln, United StatesSee the location
CompletedOne Study Center