A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults (NCT06612255), a randomized phase 1 study. The primary outcome is Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet.

2. Clinical Question

3. Trial Design

This was a phase 1, single-part, partially randomized, open-label study with a sequential model. The registry record describes 16 enrolled participants and lists the study status as terminated. The start date was 2024-06-03, and the primary completion date was 2024-09-11. The record does not state why the study was terminated.

The regimen descriptions include a tablet followed by powder sequence, a powder followed by tablet sequence, and powder-only regimens. The tablet and powder sequence descriptions specify fasted administration; the powder-only regimens are described as involving fasted or fed states. One powder-only regimen is marked optional. These descriptions establish the intended regimen structure in the record, but do not establish which regimens each participant actually received or how many participants were assigned to each sequence.

“Partially randomized” indicates that random allocation was part of the registered design, while not implying that every part of the sequential study was randomized. The allocation is recorded as randomized, and masking is recorded as none. The record does not provide further detail on the randomization procedure, sequence allocation, or any steps taken to reduce bias in an open-label study.

The primary results list 16 participants for the tablet and 16 for the powder. Those are the endpoint-specific counts in the posted results; they should not be taken as proof that every enrolled participant completed every regimen or contributed data at every timepoint. Additional details about participant flow and the reasons for any non-evaluable data 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.

First Intervention

Washout (4 days)

Second Intervention

Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints.

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 Analysis Set: all participants who received any amount of study drug.

6. Primary Endpoint

The registry lists the primary outcome as Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet, measured over Pre-dose on Day 1, up to 24 hours post-dose.

The primary endpoint was the area under the mean concentration-time curve from 0 to 24 hours after a dose of delafloxacin powder, compared with the oral tablet. The reported unit is ng*h/mL, and the stated timeframe runs from pre-dose on Day 1 to up to 24 hours post-dose. Blood samples were collected at protocol-specified timepoints.

In general, an area under a concentration-time curve represents drug exposure over a defined period: it incorporates measured concentrations across time rather than describing concentration at a single moment. A 0-to-24-hour measure therefore characterizes exposure during that specified interval. It does not, by itself, measure a clinical benefit or harm.

The endpoint is reported using geometric means and geometric coefficients of variation. In general, geometric summaries are often used for pharmacokinetic measures because concentration and exposure data can be right-skewed. A geometric coefficient of variation describes relative spread on a multiplicative scale; it is not an interval around the estimated treatment comparison. The registry record does not state the detailed rationale for choosing this endpoint or the prespecified criteria for interpreting the comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record reports geometric means for the arm-level primary outcome and a fixed-effect analysis for the comparison. These are complementary summaries: the geometric means describe the exposure values for each formulation, while the fixed-effect estimate and confidence interval summarize the registered comparison. The record does not state the detailed model specification, the fixed effects included, or the method used to calculate the interval.

What does a geometric mean describe?

General explanation: a geometric mean is calculated on a multiplicative scale and then expressed back on the original scale. It can be useful when measurements are positive and their variation is more naturally understood in terms of proportional changes than absolute changes. The reported arm summaries are 15700.0 ng*h/mL for the tablet and 8120.0 ng*h/mL for the powder. Those values are summaries, not descriptions of every participant’s exposure.

What does the geometric coefficient of variation add?

General explanation: a coefficient of variation expresses dispersion relative to the scale of the measurement. A geometric coefficient of variation is associated with log-scale variation and gives context for how spread out individual measurements are around a geometric summary. The posted values are 26.9 for the tablet and 33.9 for the powder. These values do not provide a confidence interval for the difference or ratio between formulations, and they do not show the distribution of individual measurements.

How should the confidence interval be read?

The fixed-effect estimate is 51.68, with a 90% confidence interval from 45.71 to 58.43. General explanation: a confidence interval is produced by a statistical procedure that, across repeated use under its assumptions, would cover the target value at the stated confidence level at the corresponding rate. For the particular result, the interval conveys uncertainty around the estimate. It does not assign a probability to the fixed true value, and it does not establish whether a prespecified scientific threshold has been met. The registry record does not report such a threshold, the detailed interval method, or a p-value.

Why can over-dispersion matter?

General explanation: over-dispersion means that observed variability is greater than a model assumes. When that happens, a model that understates variability can produce uncertainty intervals that are too narrow and tests that appear more decisive than warranted. This is a general consideration when evaluating statistical models; the registry record does not report an over-dispersion assessment for this endpoint. The geometric coefficients of variation alone do not establish whether a model’s assumptions were satisfied.

What does the sequential, partially randomized structure imply?

The record describes a sequential design and regimens in which participants could receive tablet and powder in different orders, alongside powder-only regimens. In general, within-participant comparisons can account for some between-person differences, while order, period, and carryover effects can matter when treatments are given sequentially. The registry record does not report the analysis details needed to determine how sequence or period was handled, whether carryover was assessed, or which participants contributed to the fixed-effect comparison. It would therefore be inappropriate to assume a particular crossover model or adjustment.

What are the planning illustrations for?

The planning illustrations use the observed effect as a basis, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is described as a stated fraction of the observed effect. Such calculations are hypothetical planning exercises, not evidence of the trial’s original design rationale and not observed power. The registry record does not report the trial’s sample-size justification. The numerical planning results should be interpreted as illustrative assumptions rather than as characteristics observed in this study.

Overall, the reported statistical information supports a description of the endpoint summaries and the fixed-effect estimate with its interval. It does not provide enough detail to reproduce the analysis or independently assess every model assumption. Further particulars about the model, missing-data handling, multiplicity, and analysis populations are not reported in the registry record.

10. Analyses Reported by the Sponsor

The registry record reports a fixed-effect analysis with an estimate of 51.68 and a 90% confidence interval from 45.71 to 58.43. This is the sponsor-reported comparison associated with the primary endpoint. A separate unadjusted recalculated estimate is not reported in the registry record, so no second numerical estimate can be placed alongside it.

The record does not flag a discrepancy between the sponsor’s analysis and a recalculation. The arm-level geometric means and coefficients of variation are available, but they do not on their own specify the comparison model or all inputs needed to reproduce the fixed-effect analysis. The fixed-effect result should therefore be cited as reported, without implying that an independent calculation confirmed the model or its assumptions.

The registry entry does not provide a p-value, a detailed model description, or a criterion for deciding whether the interval represents an acceptable relative bioavailability result. No conclusion about statistical significance, equivalence, or a clinically meaningful threshold follows from the fixed-effect estimate alone. Its interpretation depends on the scale and decision criteria, which are not reported in the registry record.

11. Multiplicity, Missing Data and Analysis Populations

The record lists four outcome measures in total. The listed secondary outcomes include maximum observed concentration (Cmax) of delafloxacin powder, area under the curve from time 0 to the last measurable concentration (AUC0-last) of delafloxacin powder, and the number of participants experiencing treatment-emergent adverse events. The primary outcome is the 0-to-24-hour area-under-the-curve comparison. One analysis is listed in the registry results.

Multiplicity arises when more than one outcome, timepoint, subgroup, or analysis is tested. In general, examining multiple results can increase the chance of obtaining an apparently notable result by chance, so a prespecified strategy may be needed when formal claims are made across several analyses. The record does not report a multiplicity adjustment, hierarchy among outcomes, or a plan describing which comparisons would support confirmatory conclusions. The presence of multiple registered measures does not establish that each was analyzed or that each was intended to support a separate claim.

The primary analysis population is described as participants who received at least one dose and were evaluable for the endpoint at the specified timepoints. The endpoint results list 16 participants for each formulation, but the record does not provide a participant flow account or explain whether any observations were missing, excluded, or imputed. It also does not report the missing-data strategy or sensitivity analyses.

The registry record therefore identifies a pharmacokinetic analysis set but does not provide enough information to judge how incomplete measurements were handled or how the multiplicity of outcomes was addressed. These omissions limit assessment of the analysis plan and the scope of inference; they do not, on their own, show that a particular analysis was biased.

12. 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 posted adverse-event counts list 16 participants at risk in each regimen group. No serious adverse events and no deaths are listed for either the tablet or powder regimen. The record lists other adverse events affecting 2 participants in the tablet group and 5 participants in the powder group. These are counts as posted; they should not be treated as evidence about event severity beyond the serious-event classification, or as a complete account of each event.

In general, zero observed serious events in a small group does not establish that serious events cannot occur. Counts from a study with 16 participants in each group offer limited information about uncommon events, and comparisons of these counts do not by themselves establish a causal difference. The record does not provide the specific terms for serious events, and none are listed among the top serious-event terms.

The adverse-event results are separate from the primary pharmacokinetic endpoint. They do not change the meaning of the concentration-time comparison, and the concentration result cannot be used to infer safety. Further detail about event timing, duration, severity for other events, or reasons for discontinuation is not reported in the registry record.

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

The result is a pharmacokinetic comparison in healthy adults between delafloxacin powder for oral suspension and the oral tablet. It describes concentration-based exposure over a defined interval and reports arm-level geometric summaries alongside a fixed-effect estimate and a 90% confidence interval. Those statistics characterize the posted endpoint and its uncertainty under the analysis used.

It does not establish whether the formulations are equivalent or whether a prespecified bioavailability criterion was met. No equivalence margin or decision threshold is reported in the registry record, and the analysis entry does not state the scale of the estimate. The confidence interval therefore cannot be judged against an unreported criterion. Nor does the result establish clinical benefit, symptom improvement, or effectiveness in people with the conditions for which delafloxacin may be used.

The participants are described as healthy, so the results should not be generalized from this record to patients with an infection or to other populations without additional evidence. A pharmacokinetic endpoint is not a direct measure of treatment success. The posted result also does not establish that one formulation is safer than the other; the adverse-event counts are limited and do not support broad safety conclusions.

The registry status is terminated, but no reason for termination is reported. That status alone does not explain the result or indicate what decisions were made about the formulations. The available record supports a bounded reading: the stated exposure summaries and fixed-effect estimate were posted for the registered primary endpoint, while the protocol details and decision criteria needed for stronger conclusions are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between a pharmacokinetic endpoint and a clinical outcome. The primary measure summarizes exposure across time, while the study population is healthy adults. That distinction matters because an exposure comparison answers a different question from whether a treatment improves a patient-centered outcome.

The record also shows why an estimate should be read together with its uncertainty. The fixed-effect estimate of 51.68 is accompanied by a 90% confidence interval from 45.71 to 58.43. The interval helps convey the precision of the comparison, but its scientific interpretation depends on the estimate’s scale and on any prespecified decision threshold. Neither the scale nor a threshold is stated in the analysis entry.

The design description adds context: the study was open-label, partially randomized, and sequential, with tablet and powder sequences as well as powder-only regimens. These features make it important to know how sequence, period, and participant-level data were handled. Those analysis details are not reported, so the registered design cannot be translated into an assumed statistical model.

Finally, the record separates what is numerically available from what remains uncertain. It posts arm summaries, a fixed-effect analysis, and adverse-event counts, but does not report a detailed model, missing-data strategy, multiplicity plan, sample-size justification, or reason for termination. Recognizing those boundaries helps readers distinguish a reported result from conclusions that the registry record cannot support.

15. 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 about the primary analysis. It identifies a fixed-effect analysis and reports an estimate and confidence interval, but does not specify the model, the scale of the estimate, the factors included, or how the interval was calculated. The reported arm summaries do not replace those details, and the analysis cannot be fully reproduced from the information recorded.

The design is described as sequential and partially randomized, but details about allocation, treatment periods, sequence handling, and possible carryover are not reported. The open-label status is recorded, but the record does not explain how awareness of treatment assignment was managed in data collection or analysis.

The primary analysis population is defined by dosing and endpoint evaluability. Although 16 participants are listed for each formulation, the record does not provide participant flow, reasons for any missing measurements, or methods for handling missing data. The sample-size justification and any prespecified decision margin are also not reported. Planning illustrations based on the observed effect are not a substitute for the original design justification.

Only one analysis is listed, while four outcome measures are recorded. A multiplicity strategy and the analysis status of the secondary outcomes are not described. The study is marked terminated, but the reason is not reported. These gaps limit assessment of precision, model assumptions, analysis choices, and the intended scope of conclusions. They do not establish that the reported result is incorrect, but they constrain what can be inferred from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults — NCT06612255.
• Registry record last updated 2026-09-11; status last verified 2026-09.
• Results first posted 2025-09-26.
• 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.

19. Record Summary

The registry record describes a phase 1, single-part, partially randomized, open-label, sequential study of delafloxacin powder for oral suspension and the oral tablet in healthy adults. It lists 16 enrolled participants, a terminated status, a start date of 2024-06-03, and a primary completion date of 2024-09-11.

The primary endpoint was the 0-to-24-hour area under the concentration-time curve. The posted geometric means were 15700.0 ng*h/mL for the tablet and 8120.0 ng*h/mL for the powder. The fixed-effect estimate was 51.68, with a 90% confidence interval from 45.71 to 58.43. The analysis entry does not state the estimate’s scale or a decision threshold.

The registry record also lists secondary outcomes and adverse-event counts. It does not report the reason for termination, detailed model specifications, a multiplicity plan, missing-data methods, or the original sample-size justification.