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 A Study of How the Body Breaks Down and Eliminates LY2623091 (NCT02242981), a na phase 1 study. The primary outcome is Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02242981 |
| Phase | Phase 1 |
| Condition | Healthy Volunteers |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
The study asks how radioactivity associated with LY2623091 is recovered over time in urine and feces after a single oral dose in healthy volunteers. It also describes planned measurements of drug concentrations in plasma and the number of metabolites detected in plasma, urine, and feces. The registry record identifies the study as a phase 1 disposition study, rather than a comparison of treatments.
Population
Healthy volunteers who received study drug. The primary endpoint population is further defined as participants with quantifiable levels of radioactivity in urine and feces. The recorded enrollment is 6; the number meeting that endpoint-specific definition is not reported in the registry record.
Intervention
A single oral dose of LY2623091. The study description says the drug was specially prepared with radiolabeled carbon, allowing radioactivity to be measured in biological samples.
Comparator
There is no separate comparator group in the registry record. The study is listed as single group, with allocation recorded as not applicable and no masking.
Primary question
What cumulative percentage of the administered radioactive dose is recovered in urine and feces over the specified collection periods? The endpoint is defined as a mean with standard deviation, but numerical results are not reported in the registry record.
The registry description also states that the study was intended to increase understanding of the drug’s appearance in blood, urine, and stool and to collect information about side effects. These aims describe what was to be assessed; without posted outcome values, the record does not establish the amount recovered or the observed concentration and metabolite findings.
3. Trial Design
This is a phase 1, completed, single-group study sponsored by Eli Lilly and Company. The registry record lists enrollment of 6 healthy volunteers. It records no allocation and no masking, consistent with a study that has no parallel treatment groups to randomize or conceal. The intervention is a single oral dose of LY2623091, prepared with radiolabeled carbon for tracking radioactivity.
The study began in 2014-09, and primary completion was recorded in 2014-11. The study description says participation could last up to 22 days per participant, not including screening, and that screening was required within 28 days before enrollment. Those details describe the planned study period; they do not establish how long each participant actually remained in the study.
The primary outcome concerns cumulative recovery of radioactivity in urine and feces at specified intervals. The schedule begins with screening for urine only and includes Day -1 and Day 1 collections at 0 to 6, 6 to 12, and 12 to 24 hours, followed by 24-hour intervals until release criteria are met, up to 504 hours. The record also lists plasma pharmacokinetic measures for LY2623091 and a count of metabolites across plasma, urine, and feces.
There is no control arm or treatment contrast. Consequently, the design is intended to describe disposition after dosing, not to estimate a difference between LY2623091 and another treatment. Detailed protocol procedures, analysis methods beyond the stated endpoint summary, and the basis for the enrollment target 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 | LY2623091 |
|---|---|
| STARTED | 6 |
| Received Study Drug | 6 |
| COMPLETED | 5 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | LY2623091 |
|---|---|
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.
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 who received study drug.
| Characteristic | Unit | LY2623091 |
|---|---|---|
| Participants analysed | 6 | |
| Age, Continuous | years | 40 (SD 14.0) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered, measured over Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of radioactive dose recovered |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is cumulative urinary and fecal recovery of LY2623091 radioactivity, expressed as a percentage of the total radioactive dose administered. It is measured over time at the collection intervals specified in the registry record. The endpoint description refers to the cumulative percentage recovered in urine and feces after administration, while the population definition includes participants who received study drug and had quantifiable radioactivity in both types of sample.
Radiolabeling permits tracking of radioactivity associated with the administered material and its metabolites. In general, recovery measurements can help describe the routes and timing by which radioactive material appears in collected samples. They do not, by themselves, identify every chemical form present; the record separately lists metabolite counts and plasma pharmacokinetic measures as outcomes.
The endpoint is summarized as a mean with standard deviation. In general, the mean describes the average observed recovery in the analyzed population, while the standard deviation describes the spread of individual measurements around that average. Neither statistic is a measure of uncertainty in the estimated mean. The registry record specifies the endpoint and summary approach but gives no numerical recovery values, standard deviations, or endpoint-specific participant count. The amount and timing of recovery therefore cannot be described from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the purpose and structure of the primary outcome, but it does not report the numerical results needed to interpret the observed excretion profile. There is no posted mean percentage of radioactive dose recovered, no standard deviation, and no reported time-specific values. It is therefore not possible to describe how much radioactivity was recovered in urine or feces, how recovery changed across collection intervals, or how variable the measurements were among participants.
This distinction matters because an endpoint definition is not an endpoint result. The schedule up to 504 hours describes when collection could continue; it does not show that all participants contributed observations at every interval or that the release criteria were met at a particular time. The number of participants included in the primary endpoint population is not reported in the registry record. Enrollment of 6 should not be treated as confirmation that all 6 had quantifiable measurements for the defined analysis population.
The registry record lists plasma AUC measures, plasma maximum concentration, and the total number of metabolites as secondary outcomes. It gives no numerical results for these outcomes either. The record therefore does not support a description of plasma exposure, peak concentration, or metabolite findings. The study description explains that side-effect information was collected, and safety counts are posted, but those counts do not fill the gap in the disposition results.
As a single-group study, the trial provides no randomized or concurrent control comparison. Even if outcome values were available, its design would describe observations after one dose in the enrolled healthy volunteers rather than estimate a comparative effect against another treatment. The small recorded enrollment also means that any descriptive estimates would be based on few participants and could be sensitive to individual observations. This is a general precision consideration, not a substitute for the missing outcome data.
No inferential analyses are listed in the registry record. It reports no confidence intervals, hypothesis tests, or model-based estimates for the primary outcome. Without those results, neither the size nor the precision of the observed recovery can be assessed. The appropriate reading is limited: the record specifies a radiolabeled disposition study and its collection plan, but does not provide primary or secondary outcome values from which to characterize the findings.
9. Statistical Methods Explained
The registry record identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. It lists no analyses. The outcome schedule and summary definition allow the intended descriptive approach to be explained, but do not establish the full statistical analysis plan. The statistical methods used beyond the posted definitions are not reported in the registry record.
What the mean and standard deviation describe
In general, a mean is the arithmetic average of participant measurements in the analysis population. For this endpoint, each measurement is a cumulative percentage of the administered radioactive dose recovered in urine and feces at a specified collection time. A mean at a given time would describe the average cumulative recovery among participants with an eligible measurement at that time. The registry record does not give those means.
In general, the standard deviation describes how dispersed participant measurements are around the mean. A larger standard deviation indicates more variation in the observed values, while a smaller standard deviation indicates that they are more clustered. It describes variability among measurements, not the precision of the estimated mean. Precision would ordinarily be assessed using an uncertainty measure such as a confidence interval, but no confidence intervals are reported in the registry record.
Why collection time matters
The endpoint is longitudinal in the descriptive sense that collections are scheduled over successive intervals after dosing. Cumulative recovery is intended to reflect the total recovered up to each specified time, rather than only the amount in one isolated collection interval. Reading such a profile generally requires attention to both the time point and the participant population contributing data at that time. The registry record gives the planned collection schedule, including urine screening, Day -1, specified Day 1 intervals, and then 24-hour intervals up to 504 hours or until release criteria are met. It does not report actual collection completion, time-specific participant counts, or numerical values.
In general, repeated measurements from the same participant are related rather than independent. Statistical summaries at each time can describe the profile, but formal analyses of change over time may need to account for within-participant correlation. Whether any such model was used is not reported in the registry record. Because no analyses are listed, no particular repeated-measures method should be attributed to this study.
Radioactivity and the endpoint scale
The endpoint is expressed as a percentage of the total radioactive dose administered. This scale relates recovered radioactivity to the administered radioactive dose and is designed to describe recovery in the collected samples. The record does not provide an accounting of all possible routes or sources of unrecovered radioactivity, and no conclusion about complete mass balance can be drawn from the endpoint definition alone. The separate metabolite outcome may provide complementary descriptive information, but its numerical findings are not reported.
The endpoint population is defined as participants who received study drug and had quantifiable levels of radioactivity in urine and feces. In general, a quantifiability requirement can mean that some participants or sample measurements do not contribute to a particular summary. The record does not state how many participants met the criterion, how measurements below quantification were handled, or whether any other observations were excluded. No imputation method or missing-data procedure is reported.
Planning assumptions are not study results
The registry record describes a sample-size planning illustration based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is a stated fraction of an observed effect. Those assumptions describe a planning illustration, not a report of observed power and not necessarily the design used for this single-group study. The illustration’s numerical estimates are not reported in the registry record. It should not be read as evidence that the study had a particular probability of detecting an effect.
In general, sample-size planning depends on the chosen effect size, variability, significance level, and design assumptions. A two-arm equal-allocation illustration is structurally different from the registered single-group disposition study, which has no comparator. The registry record does not explain how the planning illustration relates to enrollment of 6, or provide a study-specific sample-size justification.
Overall, the methods information supports a limited description: a continuous endpoint was planned for summary by mean and standard deviation, with repeated collections over time and a defined endpoint population. It does not provide the numerical data or analytical detail needed to reproduce or evaluate inferential analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome and four secondary outcome measures: three plasma pharmacokinetic measures for LY2623091 and a total metabolite count across plasma, urine, and feces. It reports five outcome measures in total and no analyses. The record does not specify whether these outcomes were tested as formal hypotheses, how they were prioritized beyond the primary and secondary labels, or whether any adjustment for multiple comparisons was planned.
In general, evaluating many outcomes can increase the chance of at least one apparently notable result when each is tested separately. Methods such as prespecifying a hierarchy or adjusting significance thresholds can address that issue, but no such approach is reported in the registry record. Since there are no posted outcome estimates or inferential tests, the effect of any multiplicity approach cannot be assessed.
The primary endpoint population requires receipt of study drug and quantifiable radioactivity in urine and feces. The number of participants meeting this definition is not reported in the registry record. The record does not state whether all enrolled participants completed each collection, how missing samples were handled, whether values below quantification were treated in a particular way, or whether any imputation was used. These are distinct issues: the endpoint’s eligibility definition is reported, but the handling and extent of missing or nonquantifiable data are not.
The record also does not report an analysis population for each secondary outcome or participant counts at the individual measurement times. It is therefore not possible to determine whether the same participants contributed to every outcome or collection interval. The planned schedule alone does not establish the completeness of the observed data.
Interim analyses and a detailed statistical analysis plan are not reported in the registry record. No conclusion about their presence or absence beyond that lack of reporting is warranted.
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 |
|---|---|---|---|
| LY2623091 | 0 | 6 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| LY2623091 | 4 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | LY2623091 |
|---|---|---|
| Constipation | Gastrointestinal disorders | 1 of 6 |
| Diarrhoea | Gastrointestinal disorders | 1 of 6 |
| Proctalgia | Gastrointestinal disorders | 1 of 6 |
| Vessel puncture site bruise | General disorders | 1 of 6 |
| Scratch | Injury, poisoning and procedural complications | 1 of 6 |
| Neck pain | Musculoskeletal and connective tissue disorders | 1 of 6 |
| Headache | Nervous system disorders | 1 of 6 |
| Erythema | Skin and subcutaneous tissue disorders | 1 of 6 |
The registry record reports 6 participants at risk for serious adverse events and 0 participants affected by serious adverse events in the LY2623091 group. It also reports 6 participants at risk for other adverse events and 4 participants affected by other adverse events. These are participant counts, not event counts, and the categories should be read separately.
The registry record lists no serious adverse event terms. This means no serious-event terms are posted in the record; it does not provide detail about the nature, timing, or severity of the four participants’ other adverse events. The number of deaths is not reported in the registry record.
These figures are descriptive safety counts for a single group of 6 participants. There is no comparator group, so they do not provide a comparative estimate of adverse-event risk. They also do not describe the frequency of every individual event, since a participant could in principle contribute more than one event, and event-level detail is not reported. The counts should be interpreted within the limited enrolled population and alongside the fact that numerical results for the primary disposition endpoint are not reported.
12. What the Result Does, and Does Not, Mean
The record describes a study designed to track radioactivity after a single oral dose of LY2623091 in healthy volunteers. Its primary endpoint was cumulative urinary and fecal recovery as a percentage of the administered radioactive dose, summarized by mean and standard deviation over scheduled collection times. The record also lists plasma pharmacokinetic outcomes and a metabolite count. These details clarify what the investigators intended to measure.
They do not reveal the observed disposition findings. Numerical results for the primary endpoint and secondary outcomes are not reported in the registry record. There is consequently no basis in the posted results to state how much radioactivity was recovered, when it was recovered, how concentrated LY2623091 was in plasma, or how many metabolites were identified. The endpoint population size and the completeness of collection are also not reported.
The safety summary reports no participants affected by serious adverse events among the 6 at risk, and reports 4 participants affected by other adverse events among 6 at risk. The record does not give serious adverse event terms, detailed descriptions of other adverse events, or a death count. These safety figures are descriptive and should not be treated as a comparison with another treatment.
In general, a single-group disposition study can characterize measured recovery and exposure in its enrolled participants when the results are available. It cannot, by design, establish a comparative treatment effect. Here, the absence of numerical outcome results further limits interpretation: the record supports a description of the study question, design, schedule, and reported safety counts, but not a quantitative conclusion about drug disposition or pharmacokinetics.
13. Why This Trial Matters Statistically
Disposition studies address a different statistical question from trials designed to compare clinical outcomes. Tracking radiolabeled material in biological samples can describe where and when radioactivity is recovered after administration. In this study, the primary endpoint was set up to summarize cumulative urinary and fecal recovery over time, with plasma pharmacokinetic and metabolite measures listed as secondary outcomes.
Statistically, the repeated collection schedule makes the timing and definition of each measurement important. A cumulative value at one time point is not interchangeable with a value from a later time point, and the number of participants contributing may vary if samples are missing or not quantifiable. The registry record gives the intended schedule and endpoint population, but not actual participant counts by time or the measurements needed to assess the profile.
The study also illustrates why design and reporting must be considered together. Enrollment was 6 and the design was single group, so any available summaries would describe a small enrolled population without a concurrent control. The posted record does not include the primary or secondary outcome values, leaving the intended statistical description unavailable. It does report safety counts, which should be kept distinct from the unreported disposition results.
For biostatistical interpretation, the key lesson is to separate an endpoint definition, an analysis plan, and an observed result. The registry specifies the first in useful detail, provides only limited information about the second, and does not report the numerical values for the main efficacy-of-measurement outcomes. A careful reading therefore identifies what was meant to be measured and what remains unquantified, rather than filling the gap with assumptions.
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 central limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. No mean percentage of radioactive dose recovered, standard deviation, time-specific estimate, or endpoint-specific sample count is available. Without these values, the excretion profile cannot be described quantitatively.
The registry record also does not report numerical results for the listed plasma pharmacokinetic outcomes or metabolite count. It does not give confidence intervals, hypothesis tests, or model-based analyses. The number of analyses is recorded as 0, and a detailed statistical analysis plan is not reported. The mean and standard deviation are specified as summary statistics, but the record does not indicate whether additional methods were used.
Enrollment was 6, and the study has no comparator group. Any descriptive observations would therefore have limited scope beyond the participants studied, and no between-treatment contrast is available. The primary endpoint population requires quantifiable radioactivity in both urine and feces, but the number meeting this definition is not reported. Actual collection completeness, missingness, and treatment of nonquantifiable observations are also not reported.
The protocol basis for enrollment, interim analyses, and a full sample-size justification are not reported in the registry record. A separate planning illustration uses assumptions for a two-arm comparison, which differ from the registered single-group design; numerical planning estimates are not reported. Finally, the safety information is limited to participant counts and does not include event-level descriptions for the other adverse events. These limitations restrict both quantitative interpretation and evaluation of how broadly the findings might apply.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of How the Body Breaks Down and Eliminates LY2623091 — NCT02242981.
- Registry record last updated 2020-06-26; status last verified 2020-06.
- Results first posted 2020-06-26.
- 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.
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18. Record Summary
NCT02242981 is a completed phase 1, single-group study of a single oral dose of radiolabeled LY2623091 in healthy volunteers. Eli Lilly and Company is listed as sponsor. Enrollment was 6; the study began in 2014-09 and primary completion was recorded in 2014-11.
The primary endpoint was cumulative urinary and fecal recovery of radioactivity as a percentage of the administered radioactive dose, summarized by mean and standard deviation over scheduled collection intervals. Secondary outcomes included plasma AUC measures, maximum plasma concentration, and the total number of metabolites in plasma, urine, and feces.
Numerical results for the primary and secondary outcomes are not reported in the registry record. The safety summary reports 0 participants with serious adverse events among 6 at risk and 4 participants with other adverse events among 6 at risk. A death count is not reported.