A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men (NCT05652647), a na phase 1 study. The primary outcome is Total Recovery of Radioactivity in Urine, Feces and Both Routes Combined, as Percentage of Orally Administered Radioactive Dose of [14C]PF-07081532.

2. Clinical Question

The study’s broader purpose was to investigate absorption, distribution, metabolism, and excretion, and to assess absolute bioavailability and fraction absorbed using a [14C]-microtracer approach. Blood, urine, and feces measurements were intended to describe how much drug or radioactivity was present in those samples over time. These are pharmacokinetic questions about the handling of the study medicine, rather than a comparison of clinical outcomes between randomized groups.

3. Trial Design

This was a completed phase 1, open-label, single-group study with two periods in a fixed sequence. The registry record lists 6 participants as enrolled. It identifies healthy participants as the study population and healthy adult male participants as the group described for the study. No randomized allocation or masking is listed.

In Period 1, participants received one oral dose of [14C]PF-07081532 30 mg (~250 nCi). The primary endpoint concerns recovery after this dose. Urine and feces were collected and analyzed for radioactivity. In Period 2, participants received oral PF-07081532 30 mg and [14C]PF-07081532 100 µg by intravenous administration. This second period is part of the pharmacokinetic investigation; it is not a separate randomized control arm.

The study description says participants stayed at the clinic for up to 21 days in Period 1 and 7 days in Period 2. Collections were scheduled across intervals following dosing, with urine and feces collection for the primary endpoint continuing up to 360 hours. The description also says participants would be involved for about 12 weeks, including follow-up by phone. The registry lists a start date of 2022-12-21, primary completion on 2023-03-15, and status as completed.

Open-label means masking was not used, according to the registry. With a single group and fixed sequence, the design is suited to characterizing pharmacokinetic measures under the study conditions. It does not provide a randomized between-group estimate of treatment effect. The registry record does not report a more detailed protocol rationale, a sample-size justification, or a statistical plan for the study beyond the endpoint and analysis-population descriptions.

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 6 participants were enrolled and treated in both Period 1 and Period 2 of the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The analysis population included all evaluable participants who had received 1 dose of \[14C\]PF-07081532 in Period 1 with complete total radioactivity concentration (urinary and fecal) data and who had no protocol deviations that might have affected the extent of excretion analysis.

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: Baseline analysis population included all participants enrolled and treated.

6. Primary Endpoint

The registry lists the primary outcome as Total Recovery of Radioactivity in Urine, Feces and Both Routes Combined, as Percentage of Orally Administered Radioactive Dose of [14C]PF-07081532, measured over 360 hours.

The primary endpoint is total recovery of radioactivity in urine, feces, and both routes combined, expressed as a percentage of the orally administered radioactive dose of [14C]PF-07081532. It summarizes how much of the administered radioactive material was measured in the collected excreta during the specified collection period. Urine and feces samples after the single Period 1 oral dose were analyzed using Accelerator Mass Spectrometry. The collection description covers urine intervals through 360 hours after dosing and feces collected across 24-hour intervals through 360 hours.

Recovery is used in excretion studies to characterize the portion of administered radioactivity accounted for in collected routes. Considering urine, feces, and their combined total gives complementary descriptions: the route-specific measures indicate where measured radioactivity was recovered, while the combined measure describes recovery across both routes. This endpoint concerns radioactivity, not necessarily unchanged parent drug alone; the study also lists pharmacokinetic outcomes for total [14C] and PF-07081532 separately.

The primary endpoint is defined as a mean with a standard deviation. In general, the mean describes the average observed recovery in the analysis population, and the standard deviation describes how spread out individual observations are around that average. Neither the observed mean nor its standard deviation is reported in the registry record, so the magnitude and variability of recovery cannot be interpreted from the registry entries available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: each participant’s recovery is expressed as a percentage of the orally administered radioactive dose. The registry identifies the summary statistic as the mean and the dispersion measure as the standard deviation. These summaries answer different questions. The mean describes the average recovery across the analysis population, while the standard deviation describes how much individual recovery values vary around that average. The record does not report either observed summary for the primary endpoint.

What does the collection window mean?

The endpoint is limited to collection through 360 hours after the Period 1 dose. The description specifies urine collection in intervals beginning with 0-12 hours and 12-24 hours, followed by subsequent 24-hour intervals up to 360 hours. Feces were collected across each 24-hour interval up to 360 hours. In general, a collection window defines the observations included in a recovery estimate. It does not, by itself, establish what happened after collection ended. No recovery values beyond the specified collection period are reported in the registry record.

Why report both routes and their combined recovery?

Urinary and fecal recovery are route-specific measurements. Reporting them separately describes the measured distribution of recovered radioactivity between those routes. The combined measure summarizes recovery across both routes. These are descriptive pharmacokinetic summaries, not a comparison between randomized groups. The registry record gives the endpoint definition but does not report the observed route-specific or combined values.

What does the analysis population include?

The primary analysis population is defined as evaluable participants who received one dose of [14C]PF-07081532 in Period 1, had complete total radioactivity concentration data for urine and feces, and had no protocol deviations that might have affected the extent of excretion analysis. This is an analysis eligibility definition. It signals that data completeness and deviations were considered relevant to the primary measure. The number of participants who met the criteria, and the specific deviations or exclusions, are not reported in the registry record.

How should uncertainty be understood?

In general, a standard deviation describes variation among observed participant measurements; it is not the same as a confidence interval for the mean. A confidence interval, in general, expresses uncertainty about an estimated quantity under the chosen statistical method and assumptions. The registry record identifies a mean and standard deviation for the endpoint but does not report their numerical values or a confidence interval. As a result, the estimate’s observed variability and statistical precision cannot be assessed from the record.

In general, small analysis populations can make estimates sensitive to the observations included, but enrollment is not necessarily the same as the number analyzed. Here, 6 participants were enrolled, while the evaluable primary analysis population is defined using data completeness and protocol-deviation criteria. The actual analysis count is not reported in the registry record, so it cannot be assumed to equal the enrollment count.

What role do the two periods play?

The study uses a fixed sequence and one group. Period 1 supplies the oral radioactive dose relevant to the primary recovery endpoint. Period 2 uses an oral dose together with an intravenous radioactive microtracer, as part of the broader investigation of absolute bioavailability and fraction absorbed. In general, fixed-sequence measurements can describe pharmacokinetic behavior under each regimen, but a sequence of regimens is not automatically a randomized comparison. The registry record does not specify a separate comparator group or a randomized treatment contrast.

The study is open-label, with no masking listed. This describes awareness of assigned procedures; it does not change the mathematical definition of the laboratory-based recovery measure. The registry record does not describe additional blinding procedures for sample analysis. It would be inappropriate to infer them.

What is not specified about the analysis?

The registry record does not report the statistical model, transformations, treatment of below-quantification values, confidence-interval method, or a plan for sensitivity analyses. It also does not report a sample-size justification, interim analyses, or a hypothesis-testing framework for the primary endpoint. These details should not be inferred from the fact that the endpoint is a mean with a standard deviation.

In general, sample-size calculations are planning tools and should not be confused with observed power after a study is complete. Any planning illustration based on an observed effect is not an estimate of the study’s actual power. Such illustrations do not replace the observed endpoint estimate, its uncertainty, or the analysis population count. The registry record does not report a protocol sample-size justification or numerical primary endpoint results.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 30 outcome measures and 0 analysis entries. The primary endpoint is one measure within a broader pharmacokinetic study that also includes outcomes such as area under the concentration-time profile, maximum observed concentration, time to maximum concentration, and elimination half-life. The record does not report a multiplicity adjustment, a hierarchy for interpreting endpoints, or a statistical analysis plan specifying which outcomes were confirmatory. Without that information, it is not possible to determine how multiple outcome assessments were handled inferentially.

In general, multiplicity arises when several hypotheses or outcomes are examined; repeated testing can increase the chance of at least one apparently notable finding. Methods to address it depend on the analysis plan and the purpose of the outcomes. No such method is reported in the registry record, so none should be assumed. The absence of a listed analysis entry also means the record does not offer a numerical analysis result to evaluate across the outcomes.

The primary analysis population requires complete total radioactivity concentration data for both urine and feces and excludes protocol deviations that might affect excretion analysis. The registry record does not report how missing collections or incomplete measurements were handled, whether any values were imputed, or the number of participants excluded from the primary analysis. It also does not provide a participant-level accounting of missing data. These omissions limit assessment of how the defined population relates to all enrolled participants.

The registry record does not report a sample-size justification or interim-analysis plan. Those details cannot be inferred from enrollment or from the endpoint definition. For any planning illustration elsewhere, participants per arm for a stated power level should be read as a planning quantity rather than observed power; the record’s stated illustration assumptions are not a substitute for a reported protocol rationale.

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 registry reports serious adverse events for 0 of 6 participants in Period 1 and 0 of 6 participants in Period 2. It reports other adverse events for 4 of 6 participants in Period 1 and 2 of 6 participants in Period 2. No deaths are listed in either period. These are participant counts within the reported period groups, not estimates of a comparative treatment effect.

The study has a single group and fixed sequence, so the Period 1 and Period 2 figures should not be read as results from independent randomized arms. The regimens also differ: Period 1 involved oral [14C]PF-07081532 30 mg, while Period 2 involved oral PF-07081532 30 mg and [14C]PF-07081532 100 µg intravenously. The registry record does not report a causal attribution for the adverse events, event-level descriptions for the other adverse events, or a statistical comparison between periods.

In general, adverse-event counts are descriptive and their interpretation depends on how events were defined, collected, and assessed. The registry lists no serious adverse-event terms. The absence of serious events in these reported counts does not establish the absence of risk, and the counts do not address the primary pharmacokinetic endpoint. The record does not report further details needed to characterize event timing, severity, or relatedness.

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

The study addresses pharmacokinetic characterization: how PF-07081532 and its associated radioactivity are measured in blood, urine, and feces after specified oral and intravenous regimens in healthy male participants. Its primary endpoint is designed to describe recovery of radioactivity in urine and feces after the oral Period 1 dose. This is a useful type of measurement for describing excretion, but the registry record does not report the observed primary endpoint values.

As a result, the record does not establish what percentage of the radioactive dose was recovered, how recovery was divided between urine and feces, or how variable the measurements were among evaluable participants. It also does not give numerical results for the broader aims of absolute bioavailability or fraction absorbed. The endpoint’s definition and collection schedule explain what was intended to be measured; they cannot stand in for the observed data.

The design is not a randomized comparison of treatments. All participants were in one group and followed a fixed sequence of two periods. The study can describe measurements under those regimens, but differences between periods cannot automatically be attributed to route or dosing because the periods are not described as randomized, like-for-like control conditions. No treatment-effect estimate for a clinical outcome is reported.

The population is also specific: healthy adult male participants. The study record does not establish how pharmacokinetic findings would apply to other populations or clinical settings. In general, a study’s population and dosing conditions define the scope of the measurements it can directly describe.

The reported adverse-event counts offer limited descriptive safety information for the two periods. They do not provide a comparative safety estimate, a causal assessment, or a complete characterization of event details. Overall, the registry record documents the study’s design, measurement goals, and some event counts, but the absence of primary numerical results prevents interpretation of the central excretion estimate. It should not be treated as evidence for a clinical benefit or lack of benefit.

13. Why This Trial Matters Statistically

Excretion studies answer a different statistical question from trials designed to compare clinical outcomes. Their central task is often to characterize concentrations, routes of recovery, and timing after a defined dose. This study’s primary endpoint is a continuous recovery measure based on radioactivity in urine and feces. Its definition makes clear which dose, routes, and collection window the measure concerns.

The two-period design also illustrates why study structure matters when reading results. Period 1 and Period 2 use different regimens, but the registry describes one group in a fixed sequence rather than a randomized comparison. Correct interpretation depends on preserving that distinction: regimen-specific pharmacokinetic measurements do not automatically create a controlled treatment contrast.

The analysis-population criteria matter as well. Requiring complete urinary and fecal data and excluding protocol deviations that might affect excretion defines whose measurements contribute to the primary analysis. Because the registry does not report how many participants met those criteria, readers cannot determine the analyzed sample size from the enrollment count alone.

Finally, statistical interpretation requires observed estimates and information about their variability. The mean and standard deviation are specified, but their numerical values are not reported in the registry record. Without them, neither the degree of recovery nor the precision of the estimate can be evaluated. This distinction between a detailed endpoint definition and a reported result is important: knowing what a study set out to measure is not the same as knowing what it found.

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 does not report the primary endpoint’s mean or standard deviation, the number of evaluable participants, or route-specific recovery values. This prevents assessment of the observed extent of excretion, variability, and precision. Although enrollment is listed as 6, the defined primary analysis population requires complete urinary and fecal data and excludes relevant protocol deviations; the number analyzed is not reported.

The study is open-label, single-group, and fixed-sequence, with no randomized control comparison. The different period regimens should therefore not be interpreted as a direct randomized contrast. The record does not report a statistical model, confidence intervals, hypothesis tests, sensitivity analyses, or a detailed analysis plan. It also does not report a sample-size justification or interim analyses.

The collection period for the primary endpoint ends at 360 hours. The endpoint is consequently tied to that collection window, and the registry does not report numerical results that would allow assessment of recovery within it. The registry record also does not describe handling of incomplete collections or missing measurements beyond the eligibility criteria for the analysis population.

The study population is healthy male participants, and the registry provides no basis for extending its measurements to other populations. Safety information is limited to period-level counts; event descriptions, timing, severity, relatedness, and a comparative analysis are not reported. These limitations constrain interpretation of the posted record without determining what the underlying study data may show.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Understand How the Study Medicine (PF-07081532) is Processed and Eliminated in Healthy Men — NCT05652647.
• Registry record last updated 2024-09-24; status last verified 2024-09.
• Results first posted 2024-09-24.
• 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

The registry describes NCT05652647 as a completed phase 1, open-label, single-group study in healthy male participants, with 6 enrolled. Participants received an oral [14C]PF-07081532 dose in Period 1 and an oral PF-07081532 dose plus an intravenous [14C]PF-07081532 microtracer in Period 2. The primary endpoint was total recovery of radioactivity in urine, feces, and both routes combined after the Period 1 oral dose, measured through 360 hours and summarized as a mean with a standard deviation.

The registry record does not report the primary endpoint’s numerical results, the number in the evaluable analysis population, or an analysis entry. It reports 0 serious adverse events among 6 participants in each period, other adverse events among 4 of 6 in Period 1 and 2 of 6 in Period 2, and no deaths in either period. The study’s fixed-sequence, single-group design is not a randomized control comparison.