This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study To Evaluate The Effect Of A Supratherapeutic Dose Of Elpipodect (MK-8189) On The QTc Interval In Participants With Schizophrenia (MK-8189-019) (NCT05893862), a randomized phase 1 study. The primary outcome is Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05893862 |
| Phase | Phase 1 |
| Condition | Schizophrenia |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 107 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled participants with schizophrenia. The registry reports enrollment of 107 participants. The primary endpoint population is described as participants who received at least one dose of MK-8189 and complied with the protocol sufficiently for the resulting data to be expected to reflect treatment effects under the underlying scientific model. The record does not give the number included in the primary analysis or explain how many enrolled participants contributed data to each treatment comparison.
Intervention
The investigational treatment was elpipodect, also named MK-8189. The trial evaluated a 48 mg dose on Day 1 and an 80 mg dose on Day 2. Its primary question focused on the 80 mg dose and the change in QTc, an electrocardiographic interval corrected for heart rate. The registry describes the trial as double-blind and randomized.
Comparator
Placebo was the primary comparator. Moxifloxacin 400 mg on Day 2, preceded by standard image placebo on Day 1, served as an active-control treatment sequence. Participants were assigned to treatment sequences that included elpipodect, placebo, and moxifloxacin in different orders. The primary endpoint description specifies that the primary comparison is MK-8189 versus placebo.
Primary question
The registry states a hypothesis that the true mean difference in QTc change from baseline for elpipodect versus placebo is less than 10 milliseconds. The endpoint was assessed after the 48 mg dose on Day 1 and the 80 mg dose on Day 2. The record does not report the numerical mean difference or its confidence interval, so it does not establish whether the stated criterion was met.
3. Trial Design
This was a randomized, double-blind, Phase 1 crossover trial with placebo and active control. Enrollment was 107, and the registry lists the study as completed. Participants were assigned to one of 6 possible treatment sequences. Across the sequences, participants received elpipodect, placebo, and moxifloxacin in counter-balanced orders, with a 5-day washout between periods.
The elpipodect treatment included 48 mg on Day 1 and 80 mg on Day 2. The moxifloxacin treatment included standard image placebo on Day 1 and moxifloxacin 400 mg on Day 2. The placebo treatment consisted of elpipodect placebo on Day 1 and Day 2. The stated aim was to compare the QTc response to elpipodect with placebo and to assess safety and tolerability. Moxifloxacin was included as an active control, and a secondary outcome measured QTc change following moxifloxacin treatment.
In a crossover design, participants receive multiple treatments in a planned order, so comparisons can use measurements from the same participant under different treatments. Counter-balancing treatment order can help distinguish treatment effects from changes associated with period or order. These are general design principles; the registry does not report the statistical model used to account for treatment sequence, period, or possible carryover effects. It also does not report the rationale for the 5-day washout or whether any specific checks for carryover were performed.
The registry gives the trial's overall enrollment but does not report sequence-specific enrollment or the number completing each period. The protocol-level details needed to assess how the intended crossover comparisons were implemented, including the handling of incomplete treatment sequences, are not reported in the registry record.
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: Treatments were administered in a counterbalanced manner on Day 1 and Day 2 of each of 3 treatment periods. Periods 1 and 2 were separated by 5-day washout. 'A' refers to MK-8189 48 mg (Day 1) and 80 mg (Day 2); 'B' refers to Standard Image Placebo (Day 1) and Moxifloxacin 400 mg (Day 2); and 'C' refers to placebo to MK-8189 (Days 1 and 2).
Overall Study
| Stage | Sequence A/B/C | Sequence A/C/B | Sequence B/A/C | Sequence B/C/A | Sequence C/A/B | Sequence C/B/A |
|---|---|---|---|---|---|---|
| STARTED | 15 | 25 | 15 | 18 | 20 | 14 |
| Treatment Period 1 + 5 Day Washout | 15 | 25 | 15 | 18 | 20 | 14 |
| Treatment Period 2 + 5 Day Washout | 14 | 16 | 15 | 15 | 18 | 14 |
| Treatment Period 3 | 13 | 13 | 12 | 13 | 15 | 12 |
| COMPLETED | 13 | 13 | 12 | 13 | 15 | 12 |
| NOT COMPLETED | 2 | 12 | 3 | 5 | 5 | 2 |
Reasons for not completing this period:
| Reason | Sequence A/B/C | Sequence A/C/B | Sequence B/A/C | Sequence B/C/A | Sequence C/A/B | Sequence C/B/A |
|---|---|---|---|---|---|---|
| Physician Decision | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 1 | 7 | 1 | 3 | 3 | 2 |
| Adverse Event | 1 | 4 | 2 | 2 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: All participants who received ≥1 dose of MK-8189, and who complied with the protocol sufficiently to ensure that generated data will likely exhibit the effects of treatment (according to the underlying scientific model), are included.
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.
Only the first 6 of 7 groups are shown.
| Characteristic | Unit | Sequence A/B/C | Sequence ACB | Sequence B/A/C | Sequence B/C/A | Sequence C/A/B | Sequence C/B/A |
|---|---|---|---|---|---|---|---|
| Participants analysed | 15 | 25 | 15 | 18 | 20 | 14 | |
| Age, Continuous | years | 45.5 (SD 12.3) | 46.0 (SD 10.9) | 43.5 (SD 9.8) | 46.8 (SD 7.6) | 44.1 (SD 9.3) | 45.9 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 3 | 8 | 3 | 4 | 3 | 3 |
| Sex: Female, Male: Male | Participants | 12 | 17 | 12 | 14 | 17 | 11 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 1 | 4 | 2 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 | 23 | 14 | 14 | 18 | 11 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 0 | 1 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 1 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 12 | 21 | 13 | 14 | 17 | 9 |
| Race (NIH/OMB): White | Participants | 3 | 3 | 2 | 2 | 1 | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 1 | 1 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following MK-8189 Treatment, measured over Day 1 (MK-8189 48 mg and placebo) and Day 2 (MK-8189 80 mg and placebo).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | ΔQTcF (msec) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in QTc corrected using Fridericia's method, reported in milliseconds. QTc is an electrocardiographic measure adjusted for heart rate so that changes in heart rate do not simply appear as changes in the measured QT interval. The trial used digital Holter electrocardiogram data. The registry describes the baseline as an average of up to 9 predose ECGs on Day 1, against which postdose measurements were compared.
The endpoint was assessed on Day 1 for MK-8189 48 mg and placebo, and on Day 2 for MK-8189 80 mg and placebo. The registry says that negative values represent a decrease from baseline and positive values represent an increase. Its stated primary comparison is elpipodect versus placebo, and its primary hypothesis concerns whether the true mean difference in QTc change is less than 10 milliseconds. This makes the endpoint useful for evaluating the size and precision of a possible treatment-related QTc change relative to a prespecified threshold. It does not, by itself, describe every aspect of cardiac safety or the broader clinical effects of treatment.
The registry identifies the endpoint as a mean and specifies a 95% confidence interval as its dispersion measure. It does not report the numerical means, treatment-placebo differences, or confidence intervals for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines the central statistical question clearly: whether the true mean difference in QTc change from baseline between elpipodect and placebo is less than 10 milliseconds. It also identifies the dose-specific assessments, using 48 mg on Day 1 and 80 mg on Day 2. However, the record does not report the numerical primary endpoint estimates. There is no reported mean change, mean treatment-placebo difference, or 95% confidence interval with which to judge the magnitude or precision of the observed QTc comparison.
Without those results, it is not possible to tell from the registry record whether the observed contrast was below the stated threshold, how close it was to that threshold, or whether the estimate was sufficiently precise to support a clear statistical conclusion. A point estimate alone would describe the estimated contrast, while its confidence interval would show the range of values reasonably compatible with the data under the analysis. The interval's position relative to the 10-millisecond criterion would be important for interpreting the stated hypothesis. Those values are not reported in the registry record.
The trial's crossover structure means that treatment comparisons may draw on measurements made in the same participants during different periods. In general, such comparisons can account for stable differences between participants, but appropriate interpretation also depends on how period, sequence, missing measurements, and potential carryover are handled. The registry describes the treatment sequences and washout but does not report the model or diagnostic analyses used for these issues.
The registry does report safety counts for several treatment groups. Those counts are descriptive and should not be treated as a substitute for the missing QTc estimates. Nor do the counts alone establish comparative risk: treatment groups have different numbers at risk, and the record does not provide a statistical comparison of adverse events. The serious-event figures and the reported counts of other adverse events should therefore be read as registry summaries, not as proof of a causal treatment difference.
Overall, the record supports a description of the design, endpoint, hypothesis, and some adverse-event counts. It does not contain the numerical primary results needed to assess the estimated QTc effect or its precision. No conclusion about whether the primary criterion was met can be drawn from the results reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary endpoint as a continuous measure summarized by a mean, with a 95% confidence interval. It does not state the fitted statistical model, the exact contrast-estimation procedure, or the method used to account for the crossover structure. The explanations below describe the statistical ideas relevant to this kind of endpoint in general; they should not be read as a description of unreported analysis procedures.
What does a mean change describe?
A mean summarizes the central value of a continuous measurement across the observations included in an analysis. For QTc change, the mean gives an average change from baseline for a treatment condition. The treatment-placebo contrast then expresses how those average changes differ. Such a contrast is more directly relevant to the stated primary question than either treatment's mean considered alone. The registry specifies that the primary comparison is MK-8189 versus placebo, but does not report the corresponding numerical means or contrasts.
A mean can conceal variation among participants. Some measurements may show increases and others decreases, while the average reflects the balance across the analyzed observations. The registry's description that negative values represent decreases from baseline and positive values represent increases helps with the direction of the endpoint. But without the actual estimates and distributions, the consistency of participant-level responses cannot be assessed.
How should a confidence interval be read?
A confidence interval is a measure of estimation uncertainty. In general, a 95% confidence interval is produced by a method designed to capture the true parameter in 95% of repeated samples under its assumptions. For an estimated treatment-placebo difference, the interval communicates which values remain compatible with the observed data and the analysis method. A narrow interval indicates greater precision than a wide interval, while neither width nor position can be assessed without the reported bounds.
For this trial, the relation of the interval to the 10-millisecond threshold would be central to evaluating the registry's stated hypothesis. If the entire interval were below that threshold, that would convey a different degree of certainty than an interval that crossed it. This is a general interpretation of interval estimates, not a claim about this trial: the registry record does not report the interval or the estimated difference.
Why does the crossover design matter?
In general, a crossover design compares treatments received by the same participants at different times. Because a participant serves as their own comparison, stable characteristics that differ between people may contribute less to the treatment contrast than they would in a design where each participant received only one treatment. That advantage depends on complete and appropriate within-participant data and a suitable analysis.
Treatment order and period can matter because measurements may change over time for reasons unrelated to the treatment being assessed. A carryover effect is a lingering effect from a treatment period that influences measurements in a later period. The registry reports counter-balanced treatment sequences and a 5-day washout between periods. It does not report whether the analysis included sequence and period terms, how carryover was evaluated, or what action was taken if relevant measurements or treatment periods were missing.
What can the active control contribute?
Moxifloxacin 400 mg was included as an active control, and change in QTc following moxifloxacin treatment was listed as a secondary outcome. In general, an active control can provide a reference treatment response within the trial's measurement and conduct framework. Its presence does not replace the primary elpipodect-placebo comparison. The registry record does not report the numerical moxifloxacin QTc result or explain how that result was used in the statistical interpretation.
What statistical details remain unavailable?
The record lists 27 analyses and identifies 10 outcome measures, but does not describe the statistical plan in enough detail to reconstruct the analysis. The specific model, assumptions, confidence-interval method, treatment of repeated measurements, and any adjustment for multiple comparisons are not reported in the registry record. Neither is the handling of missing data or the number of observations included in each endpoint analysis. Those details matter because the model and analysis population determine how the estimated treatment contrast and its uncertainty are calculated.
Sample-size illustrations, when shown with trial results, are planning exercises based on stated assumptions and an effect size. They are not observed power and do not repair missing outcome estimates. The registry description of its planning illustration says it uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. It expressly describes the illustration as computed from the observed effect rather than as the trial's own design. Since the primary observed effect is not reported in the registry record, the numerical basis for interpreting such planning scenarios is not available from this record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and 27 analyses. The primary endpoint itself includes assessments on Day 1 and Day 2, with comparisons involving the 48 mg dose, the 80 mg dose, and placebo. Secondary outcomes include QTc change following moxifloxacin treatment and several pharmacokinetic measures, including AUC0-24, AUC0-last, Cmax, C24, apparent terminal half-life, and Tmax.
When a study makes multiple statistical comparisons, the chance of at least one apparently notable result can increase if each comparison is considered independently. Multiplicity methods can adjust interpretation or statistical testing to account for a group of comparisons. The registry record does not report whether multiplicity was addressed, which outcomes or comparisons were considered confirmatory, or how the primary time points and treatment contrasts were prioritized. It is therefore not possible to infer a multiplicity strategy from the number of listed analyses alone.
The registry defines the primary population as participants who received at least one dose of MK-8189 and complied with the protocol sufficiently for their data to be expected to exhibit treatment effects under the underlying scientific model. It does not report the number included in this population, the specific compliance criteria, or the handling of participants who lacked measurements in some periods.
Missing-data methods can affect results when measurements are unavailable, particularly in a crossover trial where a participant may have data for some treatment periods but not others. The registry does not report the amount or pattern of missing endpoint data, any imputation method, or sensitivity analyses. These omissions limit assessment of the analysis population and of how robust the primary result would be to incomplete observations. The numerical primary outcome results are also not reported in the registry record, so no estimates can be evaluated alongside these unresolved analysis details.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| MK-8189 48 mg | 1 | 98 | 1.0% |
| MK-8189 80 mg | 0 | 92 | 0.0% |
| MK-8189 Placebo | 1 | 90 | 1.1% |
| Standard Image Placebo Day 1 | 0 | 89 | 0.0% |
| Moxifloxacin 400 mg Day 2 | 0 | 89 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| MK-8189 48 mg | 0 of 98 |
| MK-8189 80 mg | 0 of 92 |
| MK-8189 Placebo | 0 of 90 |
| Standard Image Placebo Day 1 | 0 of 89 |
| Moxifloxacin 400 mg Day 2 | 0 of 89 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MK-8189 48 mg | 24 of 98 |
| MK-8189 80 mg | 21 of 92 |
| MK-8189 Placebo | 15 of 90 |
| Standard Image Placebo Day 1 | 7 of 89 |
| Moxifloxacin 400 mg Day 2 | 11 of 89 |
Most frequent serious adverse event terms
| Event term | Organ system | MK-8189 48 mg | MK-8189 80 mg | MK-8189 Placebo | Standard Image Placebo Day 1 | Moxifloxacin 400 mg Day 2 |
|---|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | 1 of 98 | 0 of 92 | 0 of 90 | 0 of 89 | 0 of 89 |
| Schizophrenia | Psychiatric disorders | 0 of 98 | 0 of 92 | 1 of 90 | 0 of 89 | 0 of 89 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MK-8189 48 mg | MK-8189 80 mg | MK-8189 Placebo | Standard Image Placebo Day 1 | Moxifloxacin 400 mg Day 2 |
|---|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | 4 of 98 | 4 of 92 | 0 of 90 | 0 of 89 | 0 of 89 |
| Headache | Nervous system disorders | 1 of 98 | 1 of 92 | 5 of 90 | 1 of 89 | 0 of 89 |
| Akathisia | Nervous system disorders | 3 of 98 | 4 of 92 | 0 of 90 | 0 of 89 | 0 of 89 |
| Tachycardia | Cardiac disorders | 1 of 98 | 3 of 92 | 1 of 90 | 0 of 89 | 1 of 89 |
| Dystonia | Nervous system disorders | 5 of 98 | 1 of 92 | 0 of 90 | 0 of 89 | 0 of 89 |
| Constipation | Gastrointestinal disorders | 0 of 98 | 1 of 92 | 1 of 90 | 1 of 89 | 2 of 89 |
| Nausea | Gastrointestinal disorders | 1 of 98 | 3 of 92 | 0 of 90 | 0 of 89 | 1 of 89 |
| Insomnia | Psychiatric disorders | 2 of 98 | 2 of 92 | 0 of 90 | 0 of 89 | 1 of 89 |
| Diarrhoea | Gastrointestinal disorders | 0 of 98 | 2 of 92 | 1 of 90 | 0 of 89 | 1 of 89 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 1 of 98 | 3 of 92 | 0 of 90 | 0 of 89 | 0 of 89 |
Serious events with the highest arm-level rate: schizophrenia (1.1%), anaphylactic reaction (1.0%).
The registry reports serious adverse events, other adverse events, and deaths by treatment group. For serious adverse events, the reported number affected was 1 in the MK-8189 48 mg group and 1 in the MK-8189 Placebo group. The reported number was 0 for MK-8189 80 mg, Standard Image Placebo Day 1, and Moxifloxacin 400 mg Day 2. The numbers at risk differ among these groups; the registry reports them as 98, 92, 90, 89, and 89, respectively. Deaths were reported as 0 in every listed group.
These are descriptive counts. They do not establish whether treatment caused an event or whether event rates differ between groups. In a crossover trial, the group labels describe treatment periods, and the registry's summary does not explain how repeated exposure or participant overlap was handled in the adverse-event presentation. The record also reports other adverse events by treatment group, but those counts should not be conflated with serious adverse events.
The registry lists Schizophrenia at 1.1% and Anaphylactic reaction at 1.0% among its top serious terms. It does not establish a treatment attribution for those terms in the summary. The counts and terms are useful for describing what the registry records, but their interpretation is limited without event details, timing, exposure context, and a comparative analysis.
12. What the Result Does, and Does Not, Mean
The trial was designed to examine a specific electrocardiographic question: the mean difference between elpipodect and placebo in change from baseline in QTc. The registry states a threshold of 10 milliseconds and identifies assessments after elpipodect 48 mg on Day 1 and 80 mg on Day 2. This focus gives the study a defined endpoint and comparator, rather than making it a general evaluation of every aspect of schizophrenia treatment or safety.
The record does not report the numerical primary endpoint estimates or their confidence intervals. As a result, it does not show the size of the observed difference, how precise that estimate was, or how it related to the stated threshold. The registry record therefore cannot establish whether the primary criterion was met. The absence of those numbers should not be interpreted as evidence for either a small or a large QTc effect.
The trial's safety summaries provide counts by listed treatment group, including serious adverse events, other adverse events, and deaths. Those descriptive figures do not on their own support causal conclusions or quantify comparative risk. The registry's listed serious-event terms also do not establish that an event was caused by a particular treatment.
More generally, a QTc endpoint is a specific measured outcome. It does not by itself answer every question about tolerability, long-term safety, symptom outcomes, or treatment benefit. The registry lists pharmacokinetic outcomes and a moxifloxacin QTc outcome, but their numerical results are not included in the record. No broader conclusion about clinical efficacy or overall safety can be drawn from the primary endpoint definition alone.
The most defensible reading is thus bounded: the registry documents a randomized, double-blind crossover design and a prespecified threshold-based QTc question, and it reports some adverse-event counts. It does not supply the primary QTc estimates required to assess the answer to that question.
13. Why This Trial Matters Statistically
This trial is statistically notable for pairing a threshold-based QTc question with a randomized crossover design. The primary hypothesis is stated in terms of whether the true mean elpipodect-placebo difference in change from baseline is less than 10 milliseconds. That formulation makes the estimated difference and its uncertainty essential: interpretation depends not merely on whether an estimate is near zero, but on how its confidence interval relates to the stated threshold.
The crossover structure also makes treatment sequence and period relevant to interpretation. Participants were assigned to counter-balanced orders of elpipodect, placebo, and moxifloxacin, with a 5-day washout between periods. In general, within-participant comparisons can reduce the influence of stable differences between participants, while requiring attention to period effects, incomplete observations, and carryover. The registry gives the design details but not the statistical model or the checks used to address these considerations.
The active-control sequence adds another measurement context: moxifloxacin 400 mg on Day 2 followed standard image placebo on Day 1. A secondary outcome assessed QTc change following moxifloxacin treatment. This feature is distinct from the primary elpipodect-placebo question and should not be used to infer an unreported primary result.
Most importantly, the record illustrates why endpoint definitions and design descriptions cannot substitute for results. The primary mean differences and confidence intervals are not reported in the registry record. Without them, readers cannot assess the direction, magnitude, or precision of the main comparison, even though the question and threshold are specified. The design can be described; the answer to the primary statistical question cannot be reconstructed from the record.
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 most consequential limitation for interpreting the trial is that the registry record does not report numerical results for the primary QTc endpoint. The mean changes, treatment-placebo differences, and 95% confidence intervals are absent. This prevents assessment of the observed effect, its precision, and its relation to the stated 10-millisecond criterion.
The statistical analysis is also incompletely described. Although the record lists 27 analyses and 10 outcome measures, it does not report the model, the method for estimating treatment contrasts, the handling of repeated measurements, or whether multiplicity was addressed. The record does not explain how sequence, period, or possible carryover effects were treated in the crossover analysis. It also does not report the specific rules used to determine protocol compliance for the primary analysis population.
Missing-data information is not reported in the registry record. The number of participants with usable measurements for each treatment period, reasons for missing observations, and methods used to address incomplete data are unavailable. The record also does not report sequence-specific completion information or sensitivity analyses.
The safety summaries are limited to group-level counts and selected serious-event terms. They do not provide a comparative statistical analysis or enough event-level context to attribute events to a treatment. Finally, the record describes a planning illustration based on the observed effect, but the primary observed effect itself is not reported; the illustration cannot be used to recover the missing trial estimate or to describe observed power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study To Evaluate The Effect Of A Supratherapeutic Dose Of Elpipodect (MK-8189) On The QTc Interval In Participants With Schizophrenia (MK-8189-019) — NCT05893862.
- Registry record last updated 2026-04-29; status last verified 2026-04.
- Results first posted 2025-04-22.
- 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.
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18. Record Summary
The registry describes a completed, randomized, double-blind, Phase 1 crossover study of elpipodect in participants with schizophrenia. Enrollment was 107. Participants were assigned to counter-balanced treatment sequences involving elpipodect, placebo, and moxifloxacin, with a 5-day washout between periods.
The primary endpoint was change from baseline in Fridericia-corrected QT interval, assessed after elpipodect 48 mg on Day 1 and 80 mg on Day 2. The stated primary question was whether the true mean elpipodect-placebo difference was less than 10 milliseconds. The registry record does not report numerical results for that primary comparison.
Safety summaries include serious and other adverse-event counts and deaths by treatment group. The record also lists secondary QTc and pharmacokinetic outcomes. It does not report the full statistical model, multiplicity approach, or missing-data methods.