A Study of [¹⁴C]-LY3202626 in Healthy Male Participants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of [¹⁴C]-LY3202626 in Healthy Male Participants (NCT02555449), a na phase 1 study. The primary outcome is Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered.

2. Clinical Question

This is a pharmacokinetic and drug-disposition question, rather than a comparison of clinical outcomes between treatments. Radiolabeling allows radioactivity associated with the administered dose to be tracked in collected samples. The primary endpoint focuses specifically on radioactivity measured in feces over the recorded collection period. Other outcomes listed in the registry address plasma radioactivity and metabolites in plasma and excreta.

The study also collected information about adverse effects, according to its brief description. It was for research purposes and was not intended to treat a medical condition. The registry record does not report a treatment-versus-control question, and the single-group design does not provide a concurrent control group for comparisons.

3. Trial Design

The registry record identifies NCT02555449 as a completed phase 1 study sponsored by Eli Lilly and Company. It enrolled 6 healthy male participants. The study is recorded as single-group, with allocation marked NA and masking marked NONE. The listed intervention was [¹⁴C]-LY3202626, administered as a single oral dose containing 100 micro curies of radioactivity.

The registry lists a start of 2015-09 and primary completion of 2015-11. Its brief description says participants would stay at a clinical research unit and that the study would last about 28 days for each participant, from check-in to follow-up. These are descriptions of the planned study experience; the registry record does not provide participant-level timelines or confirm how long each participant was observed.

The primary endpoint concerns fecal excretion of radioactivity over time, expressed as a percentage of the total radioactive dose administered. Its recorded timeframe is predose, 6, 12, 24, 48, and 72 hours, then at 24 hour intervals until release criteria were met. The registry record does not describe those criteria in detail or report measurements at individual timepoints.

This design is suited to describing drug disposition after administration, but it does not include a like-for-like control group. The record does not report random assignment or a masked comparison. It also does not report the protocol, a sample-size justification, or a statistical analysis plan.

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

Analysis population for the primary outcome, as defined in the registry: All participants who received the study drug and have evaluable pharmacokinetics (PK) data.

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: All participants

6. Primary Endpoint

The registry lists the primary outcome as Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered, measured over Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met.

The primary endpoint is fecal excretion of radioactivity over time, expressed as a percentage of the total radioactive dose administered. It is recorded as a continuous measure summarized by a mean, with standard deviation as the stated measure of dispersion. The timeframe includes predose and specified post-dose collection times, followed by collection at 24 hour intervals until release criteria were met.

In general, tracking radioactivity after a radiolabeled dose can describe the amount of dose-associated radioactivity recovered in collected material over time. A percentage of the total dose provides a scale for expressing the fecal measurement relative to the administered radioactive dose. Repeated measurements can describe the time course, not just a single endpoint at one time. This is relevant to a drug-disposition study because the purpose includes examining how the body handles and eliminates the radiolabeled study drug.

The endpoint is specifically about radioactivity in feces. It should not be read as a direct measure of clinical benefit, or as a complete account of all routes of elimination. The registry record separately lists outcomes concerning plasma radioactivity and metabolites in plasma and excreta. The numerical primary-outcome values, the mean, the standard deviation, and the number of participants contributing evaluable measurements are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary measure as a continuous outcome summarized by a mean and standard deviation. It also records a repeated collection schedule, so the scientific question concerns the time course of radioactivity in feces after a single oral dose. The record does not report numerical outcome results or analysis entries. The explanations below describe the statistical meaning of the listed measures in general and distinguish that meaning from what can be concluded for this study.

What does a mean describe?

In general, a mean is a way to summarize the central level of a quantitative measure across the observations included in an analysis. For this endpoint, a mean at a collection time would describe the average fecal radioactivity expressed relative to the total radioactive dose among the participants contributing data at that time. The registry record does not report the mean values, or the number of participants contributing at each timepoint.

A mean is not a description of every participant’s value. Participants can have different measurements, and the average does not show the full distribution, the range, or whether a small number of observations strongly influence the summary. Participant-level observations and distributional summaries are not reported in the registry record.

What does the standard deviation describe?

In general, a standard deviation describes how dispersed observations are around their mean. It expresses variability in the measured values, rather than uncertainty in the estimated mean. A larger standard deviation indicates more variation among the observations relative to a smaller one, on the same measurement scale. The registry record identifies standard deviation as the dispersion measure but does not report its value for the primary endpoint.

Standard deviation and a confidence interval answer different questions. In general, a confidence interval describes uncertainty around an estimated quantity under a statistical model and analysis procedure; it is not a range expected to contain most individual observations. No confidence interval for the primary endpoint is reported in the registry record, and the analysis procedure used to produce one is not reported in the registry record.

Why collect measurements over time?

Repeated collection can describe how the measured quantity changes across the recorded post-dose timepoints. Here, the endpoint timeframe names predose, 6, 12, 24, 48, and 72 hours, then collection at 24 hour intervals until release criteria were met. In general, time-course data can help characterize the progression of an outcome rather than reducing it to one measurement. Interpreting repeated measurements also depends on knowing which observations were available at each time, how missing observations were handled, and what summaries or models were used. Those details are not reported in the registry record.

The listed endpoint is fecal radioactivity as a percentage of the total radioactive dose. It is a measure tied to radioactivity recovered in feces, not a direct measure of clinical response. The registry also identifies plasma radioactivity pharmacokinetic measures and metabolite counts as other outcomes. The record does not provide numerical findings for these measures, so they cannot be used to complete the primary endpoint interpretation.

What can the analysis entries tell a reader?

The registry record lists zero analysis entries. This means no analysis descriptions are listed in the record; it does not, by itself, establish which analyses were conducted outside the registry. The statistical analysis plan, including any model for repeated measurements, is not reported in the registry record. The record also does not report whether results were adjusted for any covariates, how outlying observations were handled, or whether assumptions were checked.

In general, a statistical model can account for relationships among repeated observations from the same participant. Measurements from one person are often related to one another, so treating them as independent may not reflect the data structure. That is a general consideration for repeated-measurement analyses, not a claim about the analysis used in this study. The registry record does not identify a repeated-measures model or its assumptions.

How should planning illustrations be understood?

The listed planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of an observed effect. In general, a sample-size calculation estimates the number of participants that a proposed design might require under specified assumptions. Such a calculation is not the same as an analysis of observed study data, and it is not observed power. The record does not report the trial’s own sample-size justification or its statistical planning process.

These assumptions are also distinct from the recorded single-group study design: no two-arm comparison is listed. Any planning illustration based on two arms is therefore hypothetical rather than a description of the trial’s allocation. Its assumptions and outputs should not be interpreted as results from the enrolled participants. The registry record does not report a numeric sample-size illustration result.

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("[¹⁴C]-LY3202626")
n   <- c(6)
m   <- c(31.3)
sp  <- c(4.24)
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  [¹⁴C]-LY3202626  6  31.300  4.240  26.850  35.750

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists seven outcome measures, including the primary fecal radioactivity endpoint and secondary measures concerning plasma radioactivity pharmacokinetics and metabolites. It lists zero analysis entries. The method used to distinguish confirmatory outcomes from exploratory outcomes, and any adjustment or other approach to multiplicity, are not reported in the registry record.

In general, examining multiple outcomes or multiple timepoints can create multiple opportunities to identify an apparently notable result. Statistical methods may address this in different ways, but no particular approach should be assumed. The record does not state whether the timepoints were analyzed separately, combined in a model, or treated descriptively. It also does not report whether a prespecified hierarchy or other testing strategy was used.

The primary-outcome population is described as participants who received the study drug and had evaluable pharmacokinetic data. The registry reports enrollment of 6, but the number included in the primary analysis is not reported in the registry record. The record does not describe missing-data rules, reasons for missing measurements, or whether analyses included all enrolled participants or only those with evaluable data. It therefore does not establish how incomplete collection schedules were handled.

The registry record also does not report a statistical analysis plan, interim-analysis procedures, or a sample-size justification. These omissions limit the ability to assess how the listed outcomes and timepoints were intended to be analyzed. They do not establish that any particular method was or was not used outside 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 registry safety figures list zero participants affected by serious adverse events among 6 at risk. For other adverse events, the record lists 4 participants affected among 6 at risk. These figures describe participants recorded as affected, not the severity or duration of each event. The registry record does not list serious adverse event terms. Death information is not reported in the registry record.

The two categories should be kept separate: the serious adverse event figure is not the same measure as the other adverse event figure. The record does not provide the event descriptions, timing, relationship to the study drug, or participant-level detail needed to interpret the four other adverse events further. It also does not report a comparison group for safety.

In general, a zero count in a small study does not establish that an event cannot occur, and a count from a single group does not show how the same participants would have fared under another treatment. These figures are descriptive registry results, not a comparative safety estimate. They should not be used to infer a broader safety profile from this study alone.

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

This study addresses a focused drug-disposition question: the time course of fecal radioactivity after a single oral dose of radiolabeled LY3202626 in healthy male participants. The registry record specifies the endpoint, its scale, its summary form, and the collection timeframe. Those details define what the study was intended to measure.

The primary endpoint values are not reported in the registry record. As a result, the record does not show the mean percentage of the radioactive dose measured in feces at any timepoint, how variable those values were, or how the pattern changed over time. It also does not report numerical results for the listed plasma radioactivity or metabolite outcomes. No quantitative conclusion about the observed disposition profile can be drawn from the endpoint descriptions alone.

The single-group design is consistent with describing measurements after a dose, but it does not provide a concurrent treatment comparator. The study was not described as a trial intended to treat a medical condition. Its record therefore does not establish comparative efficacy or answer a treatment-benefit question.

The safety figures report no participants affected by serious adverse events and report other adverse events for 4 participants among 6 at risk. The registry provides limited detail about those events, and the figures should be read as descriptive observations from this study, not as proof that serious events cannot occur or as a comparison against another treatment.

Overall, the record is informative about the study’s population, intervention, planned measurements, and some safety counts. It does not report the primary pharmacokinetic results, analysis methods, or sufficient detail to assess the precision of the endpoint estimates.

14. Why This Trial Matters Statistically

This study illustrates a different role for clinical research than testing whether one treatment outperforms another. It uses a radiolabeled single dose to investigate drug disposition in healthy male participants. The primary question concerns the time course of fecal radioactivity relative to the total radioactive dose, with additional listed measures addressing plasma radioactivity and metabolites.

Statistically, the study makes clear why an endpoint definition and a result are not interchangeable. The registry record specifies a continuous measure, a mean and standard deviation as summaries, and a collection schedule. Without the numerical measurements and the number of evaluable observations, however, readers cannot assess the observed magnitude, variability, or precision. The registry record does not report those results.

The single-group design also matters for interpretation. Descriptive pharmacokinetic measurements can address what was observed after administration in the study participants, while a treatment comparison requires a suitable comparator. No comparator group is listed. The study should not be read as a randomized comparison or as a direct test of clinical benefit.

Finally, the safety figures show how counts can be informative but limited. The record reports zero participants affected by serious adverse events and other adverse events in 4 participants among 6 at risk, but supplies no serious-event terms and little event detail. Together with the missing primary outcome results and analysis descriptions, this makes careful separation of design information, observed safety counts, and unreported efficacy or pharmacokinetic findings especially important.

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 principal limitation for interpreting the primary endpoint is that its numerical results are not reported in the registry record. The record does not provide timepoint-specific means, standard deviations, confidence intervals, or the number of evaluable observations at each collection time. It therefore does not allow assessment of the estimated excretion pattern or its precision.

The study enrolled 6 healthy male participants and used a single-group design with a single oral dose. No comparator group is listed, so the record does not support a controlled treatment comparison. The population described is limited to healthy male participants; the record does not establish how findings would apply to other populations or settings.

The stated primary-outcome population requires receipt of the study drug and evaluable pharmacokinetic data, but the number meeting that definition is not reported in the registry record. Missing-data methods and reasons for any unavailable measurements are not reported in the registry record. The analysis plan, treatment of repeated measurements, and multiplicity approach are also not reported in the registry record.

The safety reporting is limited: no serious adverse event terms are listed, and further details about the other adverse events are not reported in the registry record. Death information is not reported in the registry record. These limitations constrain interpretation of the safety counts as well as the unreported pharmacokinetic findings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of [¹⁴C]-LY3202626 in Healthy Male Participants — NCT02555449.
• Registry record last updated 2021-04-19; status last verified 2021-03.
• Results first posted 2021-04-19.
• 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

NCT02555449 is a completed phase 1, single-group study sponsored by Eli Lilly and Company. The registry record reports enrollment of 6 healthy male participants and a single oral dose of [¹⁴C]-LY3202626 containing 100 micro curies of radioactivity. The recorded start was 2015-09, and primary completion was 2015-11.

The primary endpoint is fecal excretion of radioactivity over time, expressed as a percentage of the total radioactive dose, summarized by a mean and standard deviation. The record lists seven outcome measures and zero analysis entries. Numerical primary outcome results and the analysis plan are not reported in the registry record.

The safety figures list zero participants affected by serious adverse events among 6 at risk and other adverse events affecting 4 among 6 at risk. Serious adverse event terms are not listed; death information is not reported in the registry record.