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 An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites (NCT02169427), a na phase 1 study. The primary outcome is Cumulative Recovery of [14C]-Radioactivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02169427 |
| Phase | Phase 1 |
| Condition | Parkinson's Disease (PD) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bial - Portela C S.A. |
| Results posted | Yes |
2. Clinical Question
Population
Healthy male subjects; enrollment was 6.
Intervention
A single oral dose of 100 mg OPC, with [14C]-labelled BIA 9-1067.
Comparator
None. The study is listed as single-group, with no allocation.
Primary question
How much [14C]-radioactivity was recovered over time, and through which excretion routes?
The stated purpose was to determine the rate and routes of excretion of OPC and the mass balance in urine, faeces and expired air. In general, a mass-balance study follows a radiolabel so that the recovery of drug-related radioactivity can be assessed in collected excreta. This can help describe where measured radioactivity is recovered after a dose; it does not, by itself, establish a treatment effect on a disease outcome.
The registry title identifies the participants as healthy male subjects, while the listed condition is Parkinson's Disease (PD). The record does not explain this difference. The intervention is described as 100 mg OPC, and the title specifies a single-dose oral administration of [14C]-labelled BIA 9-1067 and metabolites. No control group or alternative dose is described.
The primary outcome is cumulative recovery of [14C]-radioactivity, expressed as recovery percentage of dose. The registry lists maximum concentration and time to maximum concentration as secondary outcomes. Numerical results for these outcomes are not reported in the registry record, so the clinical question can be described but its answers cannot be quantified from the posted results.
3. Trial Design
This is a Phase 1, open-label, single-group study sponsored by Bial - Portela C S.A. The registry record lists the study as completed, with a start in 2011-03 and primary completion in 2011-07. Enrollment was 6. The title describes a single-dose oral administration of radiolabelled BIA 9-1067, and the arm description specifies 100 mg OPC.
Open-label means the study was not masked, consistent with the registry's masking designation of none. Allocation is listed as not applicable, and the model is single-group. There is no randomized comparison or like-for-like control arm. Accordingly, the record supports a descriptive account of measurements within the treated group, not a comparison of treatment groups.
Assessments focused on cumulative radioactivity recovery in urine, faeces, expired air, and in total, over post-dose collection intervals and later 24-hour collections. The listed collection schedule includes pre-dose and intervals through 216-240 hours post-dose, as well as collections on Days 14/15, 21/22, and 28/29. The description says recovery percentage of dose was derived from the area under the excretion rate from 240h onwards to infinity.
The record identifies 3 outcome measures and 0 analyses. It does not report a statistical analysis plan, sample-size justification, interim analyses, or an explanation for the selected enrollment. The sample-size assumptions describe planning illustrations based on an observed effect, rather than the study's own design rationale; no numerical planning estimates are reported in the registry record. The study's small enrollment and single-group design are important when interpreting the descriptive scope and precision of any results, but the endpoint results themselves 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.
Overall Study
| Stage | Opicapone (OPC) |
|---|---|
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
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.
| Characteristic | Unit | Opicapone (OPC) |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Cumulative Recovery of [14C]-Radioactivity, measured over pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Recovery % of dose |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is cumulative recovery of [14C]-radioactivity, with the measure expressed as recovery percentage of dose and summarized as a mean with standard deviation. The stated collection routes are urine, faeces, expired air, and total recovery. The endpoint is intended to describe the extent and timing of recovered radioactivity after administration of radiolabelled OPC.
In general, radiolabel recovery is used in mass-balance studies because radioactivity can be measured in collected material and tracked over time. Cumulative recovery describes the amount recovered up to a given collection point; the sequence of measurements can therefore indicate how recovery accrues over the collection schedule. The registry says the recovery percentage of dose was derived from the area under the excretion rate from 240h onwards to infinity. This is a description of the endpoint derivation, not a reported numerical result.
The record lists a series of early post-dose intervals and later 24-hour collections. Repeated observations across collection times can describe the course of recovery, but they do not substitute for reported participant-level values or an analysis of uncertainty. No mean, standard deviation, confidence interval, or endpoint result is reported in the registry record.
The endpoint description names AEurine, AEfaeces, AEair, and AEtotal, but the accompanying descriptions repeat wording that refers to recovery in urine. The route-specific wording is therefore not fully clear in the registry record. This limits how precisely the individual components can be interpreted from the text alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study's stated aim is descriptive: to assess excretion routes and mass balance after a single dose of radiolabelled OPC in healthy male subjects. Its design is consistent with a single-group assessment rather than a test of comparative efficacy. There is no control group, and the record does not report a randomized treatment contrast.
The registry identifies cumulative recovery of [14C]-radioactivity as the primary outcome and specifies that it is summarized as a mean with standard deviation. However, the numerical results for this primary outcome are not reported in the registry record. Without those values, the extent of recovery, its distribution across routes, and its variation among participants cannot be described quantitatively. The record also does not provide numerical results for the listed secondary outcomes of maximum concentration and time to maximum concentration.
In general, a mean describes the average observed value, while a standard deviation describes the spread of observations around that average. Neither can be interpreted without the actual estimates and the context of the measurement. A confidence interval, if reported, would give a range of values compatible with the data under the assumptions of the analysis; no confidence interval is reported for the primary outcome in the registry record.
Enrollment was 6. A small group can yield imprecise estimates, particularly when individual measurements vary, but the degree of precision cannot be assessed without the observed values and an uncertainty estimate. The stated summary statistic alone does not show whether recovery was similar across participants or whether some observations differed substantially.
The endpoint description says recovery percentage of dose was derived from the area under the excretion rate from 240h onwards to infinity. The record does not give the calculation details, estimated recovery values, or route-specific results needed to evaluate that derivation. It also contains repeated urine wording in the descriptions of several route labels, making the text ambiguous about the stated components.
The adverse-event record lists no serious adverse events among the 6 participants at risk, and other adverse events among 5 of 6 participants. These figures describe event reporting in this group; the registry does not list the specific non-serious event terms. Deaths are not reported in the registry record. Taken together, the posted information characterizes the study's design and planned measurements, but it does not provide enough outcome data to quantify mass balance or assess the variability of recovery.
9. Statistical Methods Explained
The registry identifies a continuous primary measure, summarized as a mean with standard deviation. The measure is cumulative recovery of [14C]-radioactivity, expressed as recovery percentage of dose. No numerical estimate or statistical analysis is reported in the registry record, so statistical interpretation is limited to what these methods would mean in general and what the stated endpoint is designed to capture.
What does a mean with standard deviation describe?
In general, a mean is the arithmetic average of observations. A standard deviation describes how dispersed observations are around that average. These summaries answer different questions: the mean locates the center of the observed values, while the standard deviation describes their spread. They do not show the full distribution, and neither is a direct estimate of the precision of the mean. A standard error or confidence interval is often used to express uncertainty in an estimated mean, but neither is reported for this outcome in the registry record.
With enrollment of 6, the observations would come from a small group. General statistical reasoning cautions that an average from a small group may be sensitive to individual values, especially if measurements are variable. The registry record does not provide participant-level values, the mean, or the standard deviation, so it is not possible to judge the influence of individual measurements or quantify precision.
How should collection over time be understood?
The primary endpoint is cumulative recovery measured across collection periods. In general, a cumulative measure adds recovery across successive periods, so values over time describe how the total recovered amount accrues. Measurements taken from the same participant over multiple periods are related observations, rather than independent groups. A statistical analysis of such data may need to account for that within-participant structure if it estimates trends or compares time points. The registry does not report an analysis of repeated measurements or a model for time.
The collection schedule includes pre-dose and post-dose intervals through 216-240 hours, followed by 24-hour collections on Days 14/15, 21/22, and 28/29. The endpoint description states that recovery percentage of dose was derived from the area under the excretion rate from 240h onwards to infinity. In general, an area-under-the-curve approach summarizes accumulated measurements across time. The record does not provide enough computational detail to evaluate the derivation, nor does it report the resulting estimates.
What do route-specific recovery and mass balance mean?
In general, measuring radiolabel in collected urine, faeces, and expired air allows recovery to be considered by route and in total. A mass-balance assessment aims to account for the measured radioactivity after dosing, rather than to compare clinical outcomes between treatment groups. Interpretation depends on the clarity of the route definitions, the completeness of collections, and the methods used to measure and summarize radioactivity. The registry names urine, faeces, air, and total recovery, but its descriptions repeat wording about recovery in urine. The route labels are therefore not fully clarified in the record.
What can be inferred from the analysis information?
The registry records 0 analyses. It does not describe a statistical model, hypothesis test, confidence interval procedure, treatment contrast, or plan for handling repeated observations. No p-value or adjusted estimate is reported. In general, a p-value addresses compatibility between data and a specified null model; it is not a measure of effect size or precision. Since no such result is reported, there is no basis for discussing statistical significance for the primary endpoint.
The sample-size assumptions describe planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with effects defined as fractions of an observed effect. They are explicitly planning illustrations, not the study's own design rationale. They do not establish observed power, and the registry record does not report numerical planning estimates. The single-group design also differs from the hypothetical equal-allocation, two-arm setup described in those assumptions.
Over-dispersion is a general concern when variability exceeds what a chosen statistical model assumes; it can make standard errors and tests unreliable if ignored. The registry record does not report a model or distributional assessment, so there is no evidence to assess over-dispersion for this study. More broadly, the absence of reported endpoint values and analysis details means that the statistical methods can be described, but their implementation and results cannot be independently evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures: cumulative recovery of [14C]-radioactivity as the primary outcome, plus maximum concentration and time to maximum concentration as secondary outcomes. It records 0 analyses. No multiplicity adjustment, hierarchy among secondary outcomes, or prespecified testing strategy is reported in the registry record.
In general, when several outcomes or time points are tested, the chance of at least one apparently notable result can increase if each is considered separately. Multiplicity procedures can control that risk, but the appropriate approach depends on the planned questions and analysis. The record does not state whether inferential tests were intended, and it reports no p-values or adjusted results. The sequence of collection times is part of the endpoint description; a formal comparison across those times is not reported.
The record does not describe missing-data handling, the completeness of collections, exclusions, or the analysis population for the endpoint. It also does not state whether all enrolled participants contributed to every measure. These details matter in general because incomplete collections can affect cumulative recovery estimates, while exclusions or missing observations can change the group represented by a summary. With no reported participant-level flow or analysis population, those possibilities cannot be assessed.
The safety figures use 6 participants at risk for both serious and other adverse events. The record does not explain whether the same population definition was used for efficacy-related outcomes. No statistical plan, interim analysis, or method for handling missing endpoint measurements is reported in the registry record.
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 |
|---|---|---|---|
| Opicapone (OPC) | 0 | 6 | 0.0% |
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 |
|---|---|
| Opicapone (OPC) | 5 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Opicapone (OPC) |
|---|---|---|
| Somnolence | Nervous system disorders | 2 of 6 |
| Headache | Nervous system disorders | 1 of 6 |
| Wound | Injury, poisoning and procedural complications | 1 of 6 |
| Frequent Bowel Movements | Gastrointestinal disorders | 1 of 6 |
The registry lists 6 participants at risk for serious adverse events and 0 participants affected. It also lists 6 at risk for other adverse events and 5 affected. These are participant counts in the Opicapone (OPC) group; they are not comparative estimates because the study has no control group.
The record does not list the specific non-serious adverse-event terms in the available safety summary. It also does not provide event counts by type or a fuller description of severity, timing, or attribution. The deaths field is null, so deaths are not reported in the registry record; null should not be read as a reported count of zero.
In general, adverse-event counts describe events recorded during a study and do not, on their own, establish that an event was caused by the intervention. A small single-group study also cannot provide a controlled comparison of event frequency. The posted figures should therefore be read as descriptive counts for this group, with limited detail about the events themselves.
12. What the Result Does, and Does Not, Mean
This study addresses a pharmacokinetic and excretion question: how radioactivity from a single dose of [14C]-labelled BIA 9-1067 is recovered over time and through the stated routes. Its open-label, single-group structure is suited to collecting descriptive measurements, but it does not provide a randomized comparison with another intervention or a control group.
The registry record identifies cumulative recovery as the primary endpoint and describes collection periods and a derivation involving the area under the excretion rate from 240h onwards to infinity. However, it does not report the numerical recovery results. Consequently, the posted information cannot quantify total recovery, compare the contributions of urine, faeces, or expired air, or describe variability among participants. The repeated urine wording in the route descriptions adds uncertainty about how the listed components are defined.
The record also lists maximum concentration and time to maximum concentration as secondary outcomes, but their numerical results are not reported in the registry record. No analysis results or confidence intervals are reported, so neither the size nor precision of the measured outcomes can be evaluated.
The study enrolled 6 healthy male subjects and lists Parkinson's Disease (PD) as a condition. The record does not explain that discrepancy. Its findings, even if numerical results were available, would be specific to the studied group and design; this record does not establish comparative treatment effects or clinical outcomes in people with Parkinson's Disease.
In general, a registry description can clarify what was intended to be measured, while conclusions about the observed values require reported results and analysis details. Here, the design and endpoint are described, but the numerical primary and secondary outcome findings are not reported in the registry record. The study therefore cannot be used from the posted information to quantify mass balance or the timing and route of recovery.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a clinical trial designed to compare interventions and a single-group study designed to characterize measurements after dosing. With no allocation to a comparator, its statistical question is descriptive: what recovery was observed in the enrolled group over the collection schedule? It does not estimate a between-group treatment contrast.
The use of a radiolabel and a cumulative recovery endpoint also highlights the importance of defining measurement routes and time intervals. In general, recovery over time depends on the collected material and the completeness and clarity of the measurement process. The registry gives a detailed schedule, but the repeated urine wording in several route descriptions makes the route-specific endpoint text less clear.
The record specifies a mean and standard deviation for the primary measure, yet does not report their values. That contrast is statistically important: a stated summary method does not itself communicate an observed result. Without estimates and measures of uncertainty, readers cannot assess the amount recovered or the variability in recovery. Likewise, listing secondary outcomes does not establish what those outcomes showed.
The enrollment of 6 and the absence of reported analyses also illustrate why design details, outcome values, and statistical methods all matter when interpreting a study. The record's planning assumptions describe a hypothetical two-arm calculation, whereas the actual design is single-group. Such planning illustrations are not observed power and do not substitute for a sample-size rationale or reported analysis.
Finally, the record lists a Parkinson's Disease condition but describes healthy male subjects in the title. Recognizing that mismatch, alongside the lack of numerical outcome results, is essential to keeping interpretation aligned with what the registry actually documents.
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 principal limitation for statistical interpretation is that the registry record does not report numerical primary endpoint results. It gives the endpoint definition and summary method, but no mean or standard deviation. It also does not report numerical results for maximum concentration or time to maximum concentration. Thus, the amounts recovered, their variability, and the timing of recovery cannot be quantified from the posted information.
Enrollment was 6, and the study is single-group with no randomized comparison. Those features limit the scope of inference and preclude a treatment-group contrast. The registry does not provide an explanation of sample-size selection or a sample-size justification. The planning assumptions describe an illustrative two-arm calculation rather than the design used in the study.
The endpoint description contains repeated wording referring to urine for the recovery labels that name faeces, air, and total recovery. This makes the route-specific descriptions ambiguous. Although the record specifies collection intervals and a derivation from the area under the excretion rate from 240h onwards to infinity, it does not report sufficient calculation details or resulting values to assess the derivation.
The registry lists healthy male subjects in the title and Parkinson's Disease (PD) as a condition, without explaining the difference. It does not report the analysis population, completeness of collections, missing-data handling, or exclusions. It also provides no statistical analysis plan or inferential results. These omissions make it difficult to assess the completeness, precision, and analysis of the endpoint measurements.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites — NCT02169427.
- Registry record last updated 2015-08-21; status last verified 2015-07.
- Results first posted 2015-08-21.
- 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 record describes a completed, open-label Phase 1, single-group study sponsored by Bial - Portela C S.A. It lists enrollment of 6, a start in 2011-03, and primary completion in 2011-07. The title describes a single-dose oral administration of [14C]-labelled BIA 9-1067 in healthy male subjects; the arm description specifies 100 mg OPC.
The primary outcome is cumulative recovery of [14C]-radioactivity, summarized as a mean with standard deviation and expressed as recovery percentage of dose. Maximum concentration and time to maximum concentration are listed as secondary outcomes. The stated purpose is to assess excretion and mass balance in urine, faeces, and expired air.
Numerical outcome results and statistical analyses are not reported in the registry record. The safety summary lists 0 participants with serious adverse events and 5 participants with other adverse events among 6 at risk; deaths are not reported in the registry record.