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

1. Trial at a Glance

This page covers the registry results for Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults (NCT05824091), a randomized phase 1 study. The primary outcome is Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs).

2. Clinical Question

This is a first-in-human study in healthy adults, rather than a trial designed to estimate treatment effects in people with tuberculosis. The registry lists tuberculosis as a condition, while the trial summary and title describe evaluation of MK-7762 safety, tolerability, pharmacokinetics, and food effect in healthy volunteers. The central safety question is descriptive: which adverse-event categories were reported in each posted cohort during the specified follow-up window? The record includes separate single-dose, food-effect, and multiple-dose groups, so the findings should be read in relation to the cohort and dosing context rather than as one overall comparison.

3. Trial Design

The registry describes NCT05824091 as a completed Phase 1, randomized, quadruple-masked, sequential, placebo-controlled trial. Its official title identifies single ascending dose and multiple ascending dose components in healthy adults. Enrollment is recorded as 119. The trial began on 2023-02-23 and reached primary completion on 2024-03-26.

Part 1 included single-dose cohorts and food-effect assessments. The arm descriptions state that up to five sequential cohorts were planned for escalating single doses, with 8 participants in each cohort randomized in a 3:1 ratio to MK-7762 or placebo. The record also describes a sixth cohort for food-effect evaluation. Posted adverse-event groups include fasted single-dose cohorts at 50 mg, 150 mg, 300 mg, 600 mg, and 1200 mg, along with food-effect groups at 300 mg.

Part 2 includes food-effect groups at 600 mg under fasted, fed-standard-meal, and fed-high-fat-meal conditions, and multiple-dose cohorts at 100 mg, 300 mg, and 500 mg. Pooled placebo groups are also listed for Part 1 and Part 2. The registry’s posted safety results give group-specific at-risk counts and counts with serious or other adverse events. Details such as the exact sequence and timing of all cohorts, the multiple-dose schedule, and the masking procedures are not reported in the registry record.

Randomization and placebo control can help structure comparisons, while masking can reduce the influence of expectations on care or reporting. Those design features do not, by themselves, establish that a particular comparison was prespecified or statistically tested. The registry record does not report a statistical analysis plan or a formal analysis comparing the posted cohorts.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: A total of 119 participants (including 2 replacement participants in Part 2) were dosed (48 in Part 1 and 71 in Part 2), and a total of 97 participants were exposed to MK-7762 (38 from Part 1 and 59 from Part 2).

Only the first 6 of 18 groups are shown.

Part 1: SAD Cohorts (Up to Day 7)

Part1: Period 1 FE Cohort 6(Up to Day 7)

Part1: Washout Period (8 Days)

Part1: Period 2 FE Cohort 6(Up to Day 7)

Analysis population for the primary outcome, as defined in the registry: Safety Population.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Safety Population comprised of all participants who received the study intervention.

Only the first 6 of 19 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Part 1: Percentage of Participants Reporting Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs), measured over Day 1 through Day 7.

The primary endpoint is the percentage of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 1 through Day 7. The registry defines an adverse event as an untoward medical occurrence, whether or not it is considered related to the study intervention. A TEAE is an adverse event occurring after receipt of one or more doses through the end of study for that participant.

The record defines SAEs by seriousness criteria that include death, life-threatening events, inpatient hospitalization or prolonged hospitalization, persistent disability or incapacity, congenital anomaly or birth defect, and medically significant events or reactions. AESIs are events monitored carefully by the Sponsor and subject to expedited reporting to the Sponsor. The endpoint therefore captures several complementary safety dimensions: events arising after dosing, events meeting seriousness criteria, and events singled out for focused monitoring.

Reporting event frequencies is a standard descriptive approach in early-phase studies, where characterizing tolerability and identifying potential safety concerns are important objectives. The registry’s stated unit is percentage of participants. The posted group results give counts of participants with events and counts at risk; no percentages are reproduced. The record does not report a single pooled estimate across the cohorts or an inferential comparison for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Early-phase safety results are commonly presented descriptively by dose group, cohort, or exposure condition. In this trial, the registry lists participants at risk and counts with serious and other adverse events for each posted group. A count answers how many participants in that group were recorded with an event; the at-risk count identifies the group denominator. The endpoint itself is defined as a percentage of participants, but the registry entries do not provide calculated percentages, so no percentage is inferred.

What does a participant-level event percentage represent?

In general, a participant-level percentage is the number of participants meeting an event definition divided by the number of participants assessed for that definition, expressed as a percentage. It is different from the total number of event episodes because one participant may experience more than one event. The record describes the primary outcome as the percentage of participants, but the listed results are counts. Without an explicit statement about how repeated events were handled or the precise denominator used for every endpoint category, the counts should be read as the posted participant counts rather than converted into new estimates.

Why are serious events reported separately?

In general, seriousness is a regulatory and clinical classification based on consequences such as death, life-threatening events, hospitalization, persistent disability, congenital anomaly, or other medically significant events. It is not the same as event intensity or severity. An event can be serious because of its outcome or consequences, even when its symptom intensity is not described as severe. The registry supplies its seriousness definition, and the results separately report serious-event counts and other adverse-event counts. No serious events or deaths are listed for the posted groups.

What can cohort-level results tell us?

In general, cohort-level summaries describe observed outcomes under particular study conditions. They are useful for seeing where events were recorded and for identifying patterns that may warrant further evaluation. However, groups can differ in dose, food condition, dosing schedule, cohort membership, and group size. A difference in raw counts across such groups is not, on its own, a valid estimate of a treatment effect. A formal comparison would require a defined estimand, an analysis method, and relevant uncertainty estimates. These are not reported in the registry record.

How should uncertainty be understood?

In general, a confidence interval gives a range of values compatible with the data and a specified statistical procedure. It communicates precision, not the probability that an individual outcome will occur. For rare events in small groups, estimates can be imprecise even when no event is observed. The record does not provide confidence intervals for the posted adverse-event counts, so the precision of those results cannot be quantified in the registry record reported. A zero count should not be interpreted as evidence that the true event probability is exactly zero.

What do the randomization and masking labels imply?

In general, randomization can reduce systematic differences between groups at allocation, and masking can reduce the potential influence of knowledge of assigned treatment on reporting or assessment. The registry labels this study randomized and quadruple-masked. Those labels describe design features; they do not disclose allocation concealment details, who specifically was masked, or whether masking was maintained. Such details are not reported in the registry record.

What is not available for statistical review?

The registry records 53 outcome measures and 0 analyses. The primary endpoint covers multiple event categories, and the record indicates that it was not reduced to one comparison. No p-values, confidence intervals, adjusted estimates, or formal between-group tests are reported. The registry also does not report the statistical plan, sample-size justification, interim analyses, or how missing safety observations were handled. In general, these details matter because they clarify which comparisons were planned, how uncertainty was quantified, and how incomplete data were treated. Without them, interpretation should remain descriptive and tied to the posted cohort-specific counts.

10. Multiplicity, Missing Data and Analysis Populations

The primary safety endpoint encompasses TEAEs, SAEs, and AESIs, and the registry lists many additional pharmacokinetic outcomes. Comparing multiple outcomes or multiple cohorts can raise multiplicity concerns: in general, the more statistical tests conducted, the greater the chance of at least one apparently notable result by chance. Whether and how to address multiplicity depends on the aims and prespecified analysis plan. The registry record does not report a multiplicity adjustment, a hierarchy among outcomes, or a plan identifying confirmatory comparisons. It records 0 analyses, and the primary safety endpoint was not reduced to one comparison.

Missing-data handling is also not reported in the registry record. The posted safety groups include at-risk counts, but the registry entries do not explain whether all randomized participants received treatment, whether all participants completed Day 7 follow-up, or how incomplete follow-up was handled. It is therefore not possible to assess whether the posted counts use a consistent analysis denominator for each event category or whether missing observations could affect the summaries.

The primary outcome identifies the Safety Population, but the registry does not define its membership in the registry record for interpretation. No separate intention-to-treat, per-protocol, or pharmacokinetic analysis population is described. The registry enrollment of 119 is not interchangeable with the at-risk counts listed for individual safety groups; they describe different levels of the record. In general, clear population definitions are needed to understand who contributes to each outcome and how exclusions or incomplete observations are handled. Those details, along with the statistical analysis plan, are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The serious-adverse-event figures are the posted participant counts for each listed group. Each group reports 0 serious adverse events, and each group reports 0 deaths. These are counts, not estimates of the underlying probability of a serious event. The record lists different at-risk counts for the groups, and no confidence intervals are reported.

Other adverse events are recorded in several groups, including both MK-7762 and pooled placebo groups. The counts should be interpreted within their own cohorts: the groups differ by dose, fed or fasted condition, single or multiple dosing, and at-risk count. Comparing the counts directly does not account for these differences, and the record does not report formal statistical comparisons. The results also do not specify the event terms, event severity, relatedness to treatment, or whether a participant had more than one event. Consequently, these figures describe the posted safety record but do not provide a complete account of event type or cause.

12. What the Result Does, and Does Not, Mean

The registry record documents a Phase 1 evaluation of MK-7762 in healthy adults, with single-dose, multiple-dose, placebo, and food-effect components. The posted safety data show no serious adverse events and no deaths in the listed groups during the reported Day 1 through Day 7 timeframe. Other adverse events were recorded in several groups, with counts varying across the cohort and dosing conditions. Those observations describe what was recorded; they are not a statistical demonstration that one dose or meal condition has a higher or lower event risk than another.

The results do not establish that MK-7762 is safe or unsafe for broader use. The record concerns healthy adults in an early-phase study, and it does not provide evidence about people with tuberculosis or other patient populations. The absence of serious events in the posted groups does not rule out rare harms, especially when group-level estimates and confidence intervals are not reported. Nor do the other-event counts establish that events were caused by the study drug; the registry definition includes events whether or not they are considered related.

The trial also aimed to evaluate pharmacokinetics and food effects, but numerical results for the listed pharmacokinetic outcomes are not reported in the registry record. Therefore, no conclusion about exposure, absorption, or differences by meal condition can be drawn in the registry record described. Overall, the available findings support a descriptive reading of adverse-event counts by cohort. They do not supply the inferential comparisons, event details, or precision estimates needed to make stronger claims about differences between regimens or about risks outside this study.

13. Why This Trial Matters Statistically

This trial illustrates why early-phase safety data need to be read at the level of their design. The registry combines single ascending dose, food-effect, and multiple ascending dose components, with results posted across distinct cohorts and pooled placebo groups. A single overall count would obscure those contexts, while treating every cohort as a direct comparison could imply a statistical analysis that the record does not report.

It also demonstrates a common distinction between an endpoint’s stated scale and the form of results posted. The primary outcome is described as a percentage of participants, yet the available group-level results are counts of affected participants and counts at risk. Without reported uncertainty estimates, denominators tied explicitly to each endpoint calculation, or inferential tests, the safest interpretation remains descriptive.

Finally, zero observed serious events can sound conclusive when presented without context. Statistical reasoning distinguishes an observed count from the underlying risk and recognizes that sparse events yield limited precision. The cohort-specific presentation makes that limitation visible: each group has a finite at-risk count, and the record reports no confidence intervals or formal comparisons. This trial is therefore a useful example of how design labels, endpoint definitions, and reporting detail determine what can—and cannot—be inferred from safety summaries.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record gives limited detail for interpreting the safety results beyond group counts, at-risk counts, and the endpoint definitions. Event names, severity, relatedness, timing within the follow-up period, and participant-level recurrence are not reported in the registry record. Without those details, the clinical character of the other adverse events cannot be assessed.

The record does not report confidence intervals or formal statistical comparisons for the adverse-event outcomes. Nor does it provide a statistical analysis plan, sample-size justification, interim-analysis information, or methods for handling missing observations. The endpoint is stated as a percentage, while the posted results are counts, limiting direct assessment of the stated measure from the reported details alone. The Safety Population is named but not defined.

The study includes different doses, meal conditions, and dosing schedules, so raw counts across groups should not be treated as head-to-head evidence. Although the registry identifies the trial as randomized and quadruple-masked, detailed information about allocation procedures and masking implementation is not reported. Numerical pharmacokinetic results are also absent from the registry record, despite the stated PK and food-effect objectives. These reporting limits restrict conclusions to the descriptive safety counts and design features that are recorded.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults — NCT05824091.
• Registry record last updated 2026-06-04; status last verified 2026-05.
• Results first posted 2026-06-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05824091 is a completed Phase 1 randomized, quadruple-masked, sequential, placebo-controlled trial of MK-7762 in healthy adults. The registry records enrollment of 119, a start date of 2023-02-23, and primary completion on 2024-03-26. The study included single ascending dose, food-effect, and multiple ascending dose components.

The primary safety outcome concerns TEAEs, SAEs, and AESIs from Day 1 through Day 7. No serious adverse events or deaths are listed in the posted cohort groups; other adverse events are recorded in several groups. The registry also lists pharmacokinetic outcomes, but numerical pharmacokinetic results, formal statistical comparisons, uncertainty estimates, and a detailed statistical analysis plan are not reported in the registry record.