A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects (NCT02440633), a na phase 1 study. The primary outcome is The Amounts of Radioactivity Excreted in Urine and Faeces.

2. Clinical Question

This was a drug-disposition study, not a comparison of treatment outcomes between groups. Its stated purpose was to obtain absorption, metabolism and excretion data for the parent drug and any metabolites. The primary endpoint focused on recovery of total radioactivity in urine and faeces, rather than a clinical symptom or disease outcome.

The endpoint could describe how much measured radioactivity was recovered through these routes over the stated observation period. It would not, by itself, provide separate quantities for the parent drug and each metabolite. Although the registry lists Bacterial Enteritis as a condition, the study population is described in the title as healthy male Japanese subjects.

The record identifies a single-group, open-label Phase 1 study and lists the status as completed. It does not report numerical results for the primary endpoint, so the registry record cannot establish the observed urinary or faecal recovery. It also cannot support a between-group comparison, because no comparator was included.

3. Trial Design

This was a Phase 1, open-label study of 14C-OPS-2071. The registry describes the model as single group, lists allocation as not applicable, and records masking as none. These design features are consistent with a study that administered a dose and measured drug-related radioactivity rather than assigning participants to competing treatment groups.

The intervention was an oral suspension containing 50 mg of 14C-OPS-2071. The primary endpoint description says the single dose was administered under fasting conditions on the morning of Day 1. The study objective was to obtain absorption, metabolism and excretion data for the parent drug and any metabolites. The listed condition is Bacterial Enteritis, while the title identifies the study subjects as healthy male Japanese subjects.

The registry lists enrollment as 8. This is the enrollment figure recorded for the study; it does not establish from the available information how many participants contributed data to each endpoint or completed every assessment. The safety record separately lists 8 at risk in the study group.

The study is marked completed. Its recorded start is 2015-05, and its primary completion is 2015-08. Otsuka Pharmaceutical Co., Ltd. is listed as the sponsor. There is no randomized control group, so the design is suited to descriptive evaluation of excretion within the treated group, not to estimating a treatment contrast.

The registry record does not report a protocol-level sample-size justification, detailed analysis plan, interim analysis plan, or participant flow. These omissions limit what can be inferred about how the study was planned and how the listed enrollment relates to the endpoint analysis. The record lists 3 outcome measures and 0 analyses.

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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as The Amounts of Radioactivity Excreted in Urine and Faeces, measured over up to144-168h postdose..

The primary endpoint is titled “The Amounts of Radioactivity Excreted in Urine and Faeces.” It is expressed as a percentage of the administered dose, with the mean and standard deviation specified as the summary measures. The endpoint description states that cumulative total radioactivity in faeces and urine was evaluated up to 168 hours postdose. The separate timeframe field reads “up to144-168h postdose.”

Measuring radioactivity after administration of 14C-OPS-2071 provides a way to follow drug-related material in the collected excreta. A cumulative measure describes the amount recovered over the observation period, rather than only the amount present at a single collection time. Reporting urine and faeces separately can describe recovery through each route.

The endpoint is relevant to the stated objective of obtaining excretion information. However, total radioactivity is an aggregate measure: it does not distinguish the parent drug from individual metabolites. The registry does not report numerical means or standard deviations for the urinary or faecal results, nor does it report the endpoint’s underlying participant-level data. Therefore, the measure and its intended summary can be described, but its observed magnitude and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The methods information in the record is limited. It describes a continuous primary outcome summarized using a mean and standard deviation, but it does not report numerical results or an inferential analysis for that outcome. The following explains the statistical ideas relevant to this design without implying that particular analyses were conducted.

What does a mean summarize?

For a continuous measure such as percentage of administered dose recovered, the mean is the arithmetic average of the observations included in an analysis. It offers a compact description of the group’s central value. A mean can be useful when the scientific question concerns average recovery, but it does not show the full distribution. Different sets of observations can have the same mean while differing in their spread or shape.

The registry specifies a mean for the primary endpoint, but it does not report the mean for urine or faeces. It also does not identify the number of participants contributing endpoint data or describe the handling of any incomplete collections. Thus, the intended summary can be identified, but the actual estimate and its analysis denominator cannot be checked from the registry record.

What does the standard deviation describe?

The standard deviation describes dispersion among observations around their mean. A small standard deviation relative to the measurement scale indicates values clustered more closely around the mean; a larger one indicates greater spread. This is a description of variability among observations, not a direct measure of how precisely the mean has been estimated.

For excretion data, participants may have different measured recovery patterns. A group mean without a measure of spread could conceal substantial participant-to-participant variation. Conversely, a standard deviation cannot on its own show whether differences arose from biological variation, measurement procedures, incomplete collection, or other sources. Such interpretation depends on study details and data that the registry record does not report.

How does a confidence interval differ?

In general, a confidence interval is an interval estimate intended to express uncertainty about an underlying quantity, such as a population mean. It depends on the estimate and the method used to calculate its uncertainty. It is not interchangeable with a standard deviation: the latter describes dispersion in the observed values, whereas an interval around a mean addresses uncertainty in that estimated mean.

No confidence interval for the primary endpoint is reported in the registry record. There are also no reported hypothesis tests or p-values for the endpoint. Without the estimates and their uncertainty, the precision of the observed excretion measurements cannot be evaluated from this record.

Why does the single-group design matter?

A single-group study can describe outcomes after a dose, including how measurements vary within the observed group. It does not estimate a contrast against a concurrent comparator. An uncontrolled descriptive finding cannot separate the effects associated with study-drug administration from other possible influences. For this study, a between-group effect is not the primary design quantity because no comparator group is listed.

The study is open-label, with masking listed as none. In general, lack of masking can matter when outcomes involve judgment or decisions that could be influenced by knowledge of treatment. The primary measure is described as cumulative total radioactivity in excreta, but the registry record does not describe laboratory procedures, assessment safeguards, or quality-control methods. Their implementation cannot be inferred.

What can planning calculations say?

Planning calculations are hypothetical illustrations of how a future study might be sized under specified assumptions. The assumptions described for such illustrations include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. These are planning assumptions, not evidence that this single-group study used a two-arm design.

Any sample-size illustrations based on an observed effect are not observed power and should not be read as a property of the completed study. The record does not report the primary endpoint estimates needed to evaluate those illustrations in relation to this study. It also does not report a protocol sample-size justification. As a result, the planning assumptions cannot establish that the enrollment was adequate for a particular precision or analysis objective.

What does the analysis listing establish?

The registry lists 3 outcome measures and 0 analyses. This supports a distinction between outcomes defined in the record and statistical analyses reported there. It does not establish that no analyses were performed outside the registry; it means that analysis results are not listed in the record. The registry record also does not report the statistical software, model specification, distributional checks, adjustment procedures, or a plan for handling missing values.

For a continuous excretion outcome, analysts might consider the distribution and data completeness when selecting summaries or models. Such considerations are general statistical principles, not evidence about what was done in this study. The posted record does not include data that would permit an independent assessment of the distribution, recalculation of estimates, or evaluation of model assumptions.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Feces", "Urine")
n   <- c(8, 8)
m   <- c(78, 6.08)
sp  <- c(13.1, 1.71)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Feces  8  78.000  13.100  67.048  88.952
CARM  Urine  8  6.080  1.710  4.650  7.510

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures, but no analysis results are listed. It identifies an endpoint as primary, yet the registry record does not report a multiplicity strategy for handling several outcomes or several statistical tests. Without reported tests, estimates, or a prespecified testing hierarchy, it is not possible to determine whether any multiplicity adjustment was used or whether it was considered necessary.

Missing-data handling is also not reported in the registry record. The primary endpoint depends on cumulative collection of radioactivity in urine and faeces over the specified period. The record does not state whether any collections were incomplete, how incomplete measurements were handled, or how many participants contributed to each endpoint analysis. The enrollment figure should not be treated as an endpoint-specific analysis denominator.

The analysis populations are not reported in the registry record. It is therefore unclear whether results, if available elsewhere, would be based on all enrolled participants, participants who received the dose, participants with evaluable collections, or another defined population. No sensitivity analysis for missing or incomplete observations is reported.

The registry lists 0 analyses. This means the record does not present a statistical analysis result or document how multiplicity, missingness, and analysis populations were addressed. It does not prove that these matters were unaddressed in study conduct; the methods are simply not reported in the registry record.

12. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The safety record lists 0 serious adverse events affecting participants, with 8 at risk in the 14C-OPS-2071 group. It lists 4 for other adverse events, with 8 at risk. These are the figures recorded for the group, not estimates from a comparison with a control group. The registry record does not list serious-event terms, and deaths are not reported in the registry record.

Counts should be read within the scope of the recorded categories. The figures do not indicate whether events were judged related to the study drug, how severe the other events were, when they occurred, or how long participants were followed for safety. Those details are not reported in the registry record. Nor does a count by itself quantify risk relative to an alternative treatment, because the study has no comparator group.

These safety figures are descriptive. They do not establish causation, and they should not be treated as a comparative estimate of safety. The available registry information is limited to the group-level at-risk and affected figures and the absence of listed serious-event terms.

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

The study’s intended contribution was descriptive information about absorption, metabolism and excretion after a single oral dose of 14C-OPS-2071. Its primary endpoint was cumulative total radioactivity excreted in urine and faeces, expressed as a percentage of the administered dose and summarized by a mean and standard deviation. This type of measure can characterize recovery of drug-related radioactivity over a defined observation period.

However, the registry record does not report the endpoint’s numerical results. It therefore does not show the observed mean, the standard deviation, or how much total radioactivity was recovered by either route. The record cannot support a conclusion about the magnitude or precision of urinary or faecal excretion. It also does not report metabolite-specific results, despite the stated objective referring to the parent drug and metabolites.

The single-group design allows description of observations within the treated group but cannot estimate a contrast with an untreated group or another intervention. It does not establish what would have happened under a different dose or comparator. The study’s focus on excretion measures also means that its endpoint is not a direct measure of clinical efficacy for Bacterial Enteritis.

The safety record gives group-level counts, but without comparative data, event details, or information about attribution, those figures do not establish a treatment-related cause or comparative safety profile. The record’s completed status does not fill in the missing outcome results.

In general, a result is most informative when its estimate, variability or uncertainty, analysis population, and measurement context are all available. Here, key numerical outcome and analysis details are not reported in the registry record. The appropriate conclusion is therefore limited: the study was designed to assess excretion of total radioactivity, but the posted registry information does not show the measured excretion results.

14. Why This Trial Matters Statistically

This study illustrates how a clinical trial record can document a focused measurement question even when numerical outcome results are unavailable. The study objective concerns absorption, metabolism and excretion, and the primary endpoint operationalizes part of that objective through cumulative urinary and faecal recovery of total radioactivity. Such specificity helps distinguish a drug-disposition endpoint from a clinical outcome.

It also illustrates why the summary statistic matters. The registry specifies a mean and standard deviation, which would convey the central value and the spread of measurements if numerical results were reported. Without those values, readers cannot judge either the observed level of excretion or participant-to-participant variability. A defined endpoint is not itself an estimate.

The design is equally important to interpretation. Because this is a single-group, open-label study with no comparator, its intended descriptive information should not be recast as a treatment comparison. Statistical language about effects between groups would require a comparison that the record does not describe.

Finally, the record separates outcome definitions from reported analyses: it lists 3 outcome measures and 0 analyses. That distinction is useful when assessing evidence. A study may have a stated endpoint and completed status while the registry record still lacks estimates, uncertainty measures, analysis populations, and missing-data details. Recognizing these gaps prevents overinterpretation and clarifies what additional reporting would be needed for a fuller statistical assessment.

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 central limitation for interpretation is that the registry record does not report numerical results for the primary endpoint. Means, standard deviations, endpoint-specific denominators, and uncertainty intervals are not available, so the observed excretion levels and their precision cannot be assessed. The record lists 0 analyses, leaving no reported statistical result to evaluate or independently check.

The endpoint measures total radioactivity in urine and faeces. It does not, as described, separate the parent drug from individual metabolites. Although the stated objective includes parent drug and metabolites, metabolite-specific results are not reported in the registry record. The timeframe field says “up to144-168h postdose.” while the endpoint description states that cumulative excretion was evaluated up to 168 hours postdose.

The single-group design has no comparator, which limits interpretation to description rather than comparative effects. The registry does not report the endpoint analysis population, the completeness of excreta collection, missing-data procedures, laboratory methods, or the protocol’s sample-size justification. These details would be relevant to assessing measurement quality and the relationship between enrollment and the precision of the estimates.

Safety information is also limited: the record provides group-level figures but does not report event terms for serious events, attribution, timing, or details of the other adverse events. Deaths are not reported in the registry record. These limitations are specific to the information recorded and should not be taken as evidence about study conduct beyond what the registry reports.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects — NCT02440633.
• Registry record last updated 2016-10-21; status last verified 2016-08.
• Results first posted 2016-08-24.
• 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.

19. Record Summary

The registry record describes NCT02440633 as a completed, open-label Phase 1, single-group study sponsored by Otsuka Pharmaceutical Co., Ltd. It lists enrollment as 8, a start date of 2015-05, and primary completion in 2015-08. The intervention was a single oral dose of a suspension containing 50 mg of 14C-OPS-2071 under fasting conditions.

The primary endpoint concerned cumulative total radioactivity excreted in urine and faeces, expressed as a percentage of the administered dose and summarized by mean and standard deviation. The endpoint description specifies evaluation up to 168 hours postdose. The registry lists 3 outcome measures and 0 analyses.

Numerical primary-endpoint results, endpoint-specific analysis populations, missing-data procedures, and metabolite-specific findings are not reported in the registry record. The safety figures list 0 serious adverse events and 4 other adverse events, with 8 at risk in the group.