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 Single Dose Study of LY3023703 in Healthy Participants (NCT01632579), a randomized phase 1 study. The primary outcome is Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01632579 |
| Phase | Phase 1 |
| Condition | Healthy Volunteers |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy participants were eligible for this phase I study. The safety population was defined as participants who received at least one dose of study drug or placebo, whether or not they completed all protocol requirements. The registry record reports enrollment of 30, but does not report a separate count for each analysis population.
Intervention
The intervention was oral LY3023703, given as single escalating doses from 0.1 mg up to 60 mg. The arm description allows up to six escalating doses and up to two occasions per participant, with at least a 3 week washout period between occasions.
Comparator
Placebo was given orally as a single dose on up to one occasion. Celecoxib was included as an open-label positive control, as a single 400 mg oral dose on one occasion. The record describes washout periods of at least a 3 week duration.
Primary question
The primary endpoint counts participants with one or more investigator-assessed possibly drug-related adverse events, or any serious adverse event, from baseline up to Day 7 post-dose. This is a short-term safety and tolerability question in healthy participants, not a question about treatment of a medical condition.
3. Trial Design
This was a randomized, double-blind, phase I, crossover study of LY3023703 in healthy participants. Its official title describes a single-dose, dose-escalation study evaluating safety and tolerability. The registry lists 30 participants enrolled, and the study status is completed. The recorded start was 2012-06, and primary completion was 2012-09.
The study included oral LY3023703, placebo, and celecoxib. LY3023703 was administered as single escalating doses from 0.1 mg up to 60 mg, with the arm description allowing up to six escalating doses and up to two occasions per participant. Placebo was administered on up to one occasion. At least a 3 week washout period separated occasions described for LY3023703 and placebo. Celecoxib was a positive control: a single 400 mg dose, given open label on one occasion, with at least a 3 week washout period.
The crossover model means the study was not described simply as a comparison of separate groups receiving one treatment each. Participants could have contributed observations in more than one treatment or dose period. Consequently, the risk counts reported for individual dose groups should not be added to estimate the number of distinct participants. The record does not give the sequence assignments, period-specific participant flow, or a detailed account of how the randomization and masking were implemented. It also does not report the planned sample-size justification or a statistical analysis plan.
The study purpose included safety, tolerability, drug concentrations in blood, and how long the body takes to eliminate the drug. Listed secondary outcomes also cover pharmacokinetic and pharmacodynamic measures. Results for those outcomes 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.
Before assignment: The study had 3 periods. Period 1: 0.1 milligram (mg), 0.5 mg, 2.5 mg LY3023703 or placebo. Period 2: 10 mg, 30 mg, 60 mg LY3023703 or placebo. Period 3: 400 mg celecoxib. There was at least a 3-week washout between periods and at least 7 days between dosing of each cohort in Periods 1 and 2.
Only the first 6 of 9 groups are shown.
Period 1 (First Intervention)
| Stage | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 |
|---|---|---|---|---|---|---|
| STARTED | 2 | 6 | 2 | 2 | 6 | 2 |
| Received at Least 1 Dose | 2 | 6 | 2 | 2 | 6 | 2 |
| COMPLETED | 2 | 6 | 2 | 2 | 6 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Washout Period
| Stage | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 |
|---|---|---|---|---|---|---|
| STARTED | 2 | 6 | 2 | 2 | 6 | 2 |
| COMPLETED | 1 | 6 | 2 | 2 | 6 | 2 |
| NOT COMPLETED | 1 | 0 | 0 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 |
|---|---|---|---|---|---|---|
| Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
Period 2 (Second Intervention)
| Stage | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 |
|---|---|---|---|---|---|---|
| STARTED | 1 | 6 | 2 | 2 | 6 | 2 |
| Received at Least 1 Dose | 1 | 6 | 2 | 2 | 6 | 2 |
| COMPLETED | 0 | 6 | 2 | 2 | 6 | 2 |
| NOT COMPLETED | 1 | 0 | 0 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 |
|---|---|---|---|---|---|---|
| Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
Washout Period
| Stage | Cohort 1 Sequence 1 | Cohort 1 Sequence 2 | Cohort 1 Sequence 3 | Cohort 2 Sequence 1 | Cohort 2 Sequence 2 | Cohort 2 Sequence 3 |
|---|---|---|---|---|---|---|
| STARTED | 0 | 6 | 2 | 2 | 6 | 2 |
| COMPLETED | 0 | 6 | 2 | 2 | 6 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety population: participants who received at least 1 dose of study drug or placebo, whether or not he/she completed all the protocol requirements.
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 randomized participants.
| Characteristic | Unit | Entire Study Population |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 47.0 (SD 10.9) |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 19 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 29 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 26 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE, measured over Baseline up to Day 7 post-dose.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with one or more drug-related adverse events or any serious adverse event, measured from baseline up to Day 7 post-dose. For the drug-related component, an event counted when the investigator considered it possibly related to study drug. Serious adverse events counted regardless of the investigator’s view of relatedness. The endpoint is therefore a participant-level safety measure, rather than a count of all event occurrences: a participant with multiple qualifying events still belongs to the group of participants with one or more events.
Safety and tolerability are central concerns in an early-phase dose-escalation study. Recording whether participants experienced qualifying events can describe short-term event occurrence across dose groups and comparators. Including any serious adverse event regardless of attribution also preserves a serious-event safety signal even when a causal relationship is not judged possible.
The registry describes the primary endpoint’s timeframe and population, but does not report an inferential comparison for it. The posted adverse-event summaries separately report serious events and other non-serious events, with the latter summaries including events regardless of possible study-drug relatedness. Those counts should not be treated as an exact reconstruction of the primary endpoint, whose relatedness rule differs for non-serious events. The endpoint does not measure efficacy or establish what would happen with longer exposure.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event counts show zero serious adverse events in each listed group: placebo, each LY3023703 dose group, and celecoxib. The registry also reports counts of participants with other non-serious adverse events: 3 for placebo, 1 for LY3023703 0.1 mg, 0 for LY3023703 0.5 mg, 2 for LY3023703 2.5 mg, 0 for LY3023703 10 mg, 4 for LY3023703 30 mg, 2 for LY3023703 60 mg, and 2 for celecoxib. These other-event summaries are regardless of possible study-drug relatedness.
These are descriptive counts, not evidence of a statistically established difference between groups. The registry record lists no analyses, and it does not report a formal comparison, confidence interval, or p-value for the primary endpoint. The relatedness criteria for the primary endpoint also mean that the non-serious-event counts cannot by themselves identify how many participants met the primary endpoint. The investigator’s assessment of possible relationship is required for that component, and the posted summary does not provide those classifications by group.
The reported risk counts vary among groups. In a crossover study, a participant may receive more than one dose or comparator on separate occasions, so group counts do not necessarily represent mutually exclusive sets of people. The record describes up to six LY3023703 doses and up to two occasions per participant, and reports an enrollment of 30. It does not provide enough detail to reconstruct participant-level treatment sequences, repeated observations, or the exact analysis population for each result. The arm counts should therefore be read as group-specific denominators, not added to produce a total number of distinct participants.
The endpoint’s observation window extends from baseline up to Day 7 post-dose. The results speak to the safety information recorded within that timeframe and do not describe events outside it. The study’s healthy-participant population and single-dose design also limit what can be inferred about other populations or longer-term use. The record lists pharmacokinetic and pharmacodynamic outcomes, but does not report their results. In sum, the available figures describe reported adverse-event counts; they do not establish a comparative effect, quantify uncertainty around a treatment contrast, or answer the study’s other listed outcome questions.
9. Statistical Methods Explained
The endpoint is a count of participants who experienced one or more qualifying events. This is a binary outcome at the participant level: each person either meets the endpoint definition or does not. That differs from counting every event, because repeated events in one participant do not turn that participant into multiple participants for this measure. The endpoint combines investigator-assessed possibly drug-related adverse events with any serious adverse event, which is included regardless of relatedness.
What does a participant count convey?
A participant count gives a direct description of how many people in a group met the stated event criterion. A count is easiest to interpret alongside its group denominator, but the denominator does not by itself convey precision. When event counts are small, estimates of event frequency can be uncertain. A confidence interval, when reported, describes a range of values compatible with the data under the specified statistical method. The registry record does not report confidence intervals or a formal analysis for this endpoint.
Why is relatedness important?
The endpoint’s non-serious-event component depends on the investigator’s judgment that an event was possibly related to study drug. Its serious-event component includes any serious event whether or not a relationship was considered possible. The posted summaries distinguish serious events from other non-serious events and state that the latter are reported regardless of possible relatedness. As a result, the other non-serious-event counts are not interchangeable with the endpoint’s drug-related adverse-event component. Without group-level relatedness classifications, the primary endpoint cannot be reconstructed from those counts alone.
How should the crossover design affect interpretation?
In a crossover study, participants can receive different interventions or dose levels across separate periods. Measurements from the same participant may therefore be related rather than independent. A statistical comparison in such a design may need to account for the within-participant structure, treatment sequence, and period. The registry record does not report the analysis model or enough sequence-level detail to determine how these features were handled. The design description alone does not establish that a particular model or adjustment was used.
For descriptive safety counts, the group-specific risk sets are still useful as the denominators shown for each group. However, because the study allows repeated treatment occasions, those denominators should not be summed as though every group represented a separate, non-overlapping set of participants. The enrollment figure is not a substitute for an endpoint-specific analysis denominator.
What can be concluded without a reported comparison?
Descriptive counts show what the registry reports for each group. They do not quantify the uncertainty of a difference between groups or establish that any observed variation is more than chance variation. A p-value would address a specified statistical hypothesis under a specified analysis; it would not measure the size or clinical importance of an effect. No such analysis is reported in the registry record. No confidence interval or adjusted estimate is reported either.
The statistical plan, sample-size justification, and any interim analyses are not reported in the registry record. The study’s enrollment and the group-specific counts should not be used to infer that it had adequate power to detect a particular safety difference. The sample-size illustration associated with the observed effect is a planning calculation, not observed power; without a reported comparative estimate and its uncertainty, it cannot supply evidence that the groups differ.
The record lists maximum concentration and area under the concentration curve as pharmacokinetic outcomes, and several prostaglandin-related measures as pharmacodynamic outcomes. These outcomes can characterize exposure and biological response, but their results and analysis methods are not reported in the registry record. General statistical interpretation of those measures would require their estimates, variability, timing, and analysis details. The presence of an outcome in the registry does not mean its result is available or supports a conclusion.
10. Multiplicity, Missing Data and Analysis Populations
The study lists several outcome measures: the primary safety endpoint and secondary pharmacokinetic and pharmacodynamic outcomes. The secondary measures include maximum concentration and area under the concentration curve for LY3023703, as well as changes in ex vivo prostaglandin E synthesis and urinary prostaglandin, prostacyclin, and thromboxane metabolite excretion. Results and analysis counts for these outcomes are not reported in the registry record.
When a study evaluates multiple outcomes, dose levels, time points, or comparisons, the chance of obtaining an apparently notable result by chance can increase. A statistical plan may address this multiplicity through prespecified primary comparisons, adjustment procedures, or a hierarchy of testing. The registry record does not report whether any such approach was planned or used. It also does not report interim analyses or a prespecified hierarchy for the listed outcomes. No multiplicity adjustment should therefore be assumed.
The record identifies a safety population as participants who received at least one dose of study drug or placebo, whether or not they completed all protocol requirements. It does not report the number included in each analysis or explain how missing observations were handled. Missing-data methods, reasons for missingness, and outcome-specific completeness are not reported in the registry record.
These gaps matter because an outcome’s estimate and uncertainty depend on which observations were available and how incomplete data were treated. In a crossover study, period-level missingness may also affect which within-participant comparisons can be made. The posted descriptive safety counts do not resolve those questions. The absence of reported analysis details should be treated as uncertainty about the statistical handling, not as evidence that missingness or multiplicity had no effect.
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 |
|---|---|---|---|
| Placebo | 0 | 12 | 0.0% |
| LY3023703 0.1 mg | 0 | 8 | 0.0% |
| LY3023703 0.5 mg | 0 | 8 | 0.0% |
| LY3023703 2.5 mg | 0 | 8 | 0.0% |
| LY3023703 10 mg | 0 | 7 | 0.0% |
| LY3023703 30 mg | 0 | 8 | 0.0% |
| LY3023703 60 mg | 0 | 8 | 0.0% |
| Celecoxib | 0 | 28 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 3 of 12 |
| LY3023703 0.1 mg | 1 of 8 |
| LY3023703 0.5 mg | 0 of 8 |
| LY3023703 2.5 mg | 2 of 8 |
| LY3023703 10 mg | 0 of 7 |
| LY3023703 30 mg | 4 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | LY3023703 0.1 mg | LY3023703 0.5 mg | LY3023703 2.5 mg | LY3023703 10 mg | LY3023703 30 mg |
|---|---|---|---|---|---|---|---|
| Arthropod bite | Injury, poisoning and procedural complications | 0 of 12 | 0 of 8 | 0 of 8 | 1 of 8 | 0 of 7 | 1 of 8 |
| Headache | Nervous system disorders | 2 of 12 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 0 of 8 |
| Lacrimation increased | Eye disorders | 0 of 12 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 1 of 8 |
| Cytomegalovirus infection | Infections and infestations | 0 of 12 | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 0 of 8 |
| Upper respiratory tract infection | Infections and infestations | 1 of 12 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 0 of 8 |
| Dehydration | Metabolism and nutrition disorders | 0 of 12 | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 0 of 8 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 12 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 1 of 8 |
| Myalgia | Musculoskeletal and connective tissue disorders | 0 of 12 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 1 of 8 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 0 of 12 | 0 of 8 | 0 of 8 | 1 of 8 | 0 of 7 | 0 of 8 |
| Urticaria | Skin and subcutaneous tissue disorders | 1 of 12 | 0 of 8 | 0 of 8 | 0 of 8 | 0 of 7 | 0 of 8 |
The serious adverse-event count is zero in every listed group: placebo, LY3023703 0.1 mg, LY3023703 0.5 mg, LY3023703 2.5 mg, LY3023703 10 mg, LY3023703 30 mg, LY3023703 60 mg, and celecoxib. The corresponding reported group risk counts are 12, 8, 8, 8, 7, 8, 8, and 28. These counts describe the registry’s group-specific safety summaries; crossover participation means they should not be added to estimate a number of distinct participants.
A zero count means no serious adverse events were recorded in that group in the posted results. It does not prove that the underlying risk is zero, and it does not rule out events outside the reported observation period. The primary endpoint covers baseline up to Day 7 post-dose. The registry record does not report confidence intervals or a formal statistical comparison for the serious-event counts.
The record’s death fields are not populated with counts, so deaths are not reported in the registry record. Other non-serious adverse-event counts are separate from serious-event counts and are reported regardless of possible relatedness. They should not be read as counts of primary-endpoint events without the investigator’s relatedness assessments.
12. What the Result Does, and Does Not, Mean
The results support a narrow descriptive statement: the registry reports no serious adverse events in the listed groups and reports the stated counts of other non-serious adverse events. These figures describe events recorded in a phase I study of healthy participants during a short post-dose observation window. They do not constitute a formal statistical comparison between LY3023703, placebo, and celecoxib.
The primary endpoint is not simply the count of all non-serious events. It includes non-serious events judged possibly related to study drug by the investigator, together with any serious adverse event regardless of relatedness. The registry’s non-serious-event summaries include events regardless of possible relatedness. Because the group-level attribution details are not reported, the posted non-serious counts cannot establish the primary endpoint counts or show how many events investigators considered possibly drug-related.
Zero reported serious events should not be interpreted as proof that serious events cannot occur. A finite study with a limited observation period can describe what was recorded in that study, but it cannot establish the absence of risk. The record does not report uncertainty estimates or an inferential analysis for the safety endpoint, so the precision of any comparison is not quantified.
The study was designed to examine single-dose safety and tolerability and also listed pharmacokinetic and pharmacodynamic outcomes. The record does not report results for the latter outcomes. These data therefore do not establish pharmacokinetic exposure, biological effects, efficacy, or outcomes with repeated or longer-term use. The study involved healthy participants and is not described as intended to treat a medical condition. Its findings should be understood within those recorded design and population limits, without extending the interpretation to other settings.
13. Why This Trial Matters Statistically
This study illustrates why the design and endpoint definition matter when reading early-phase safety results. The crossover model permits different treatment or dose periods within a participant, so group-level counts are not necessarily independent or mutually exclusive. A reader should not add group denominators or treat each dose group as a separate set of people. The registry’s description of up to six escalating LY3023703 doses and up to two occasions per participant makes participant-level treatment sequences especially relevant to any comparative analysis.
The endpoint also combines two different attribution rules: investigator-assessed possibly related non-serious adverse events and any serious adverse event. Meanwhile, the other non-serious-event summaries include events regardless of possible relatedness. That distinction shows why a result label cannot be interpreted without its operational definition. Similar-sounding safety counts can represent different outcomes.
Finally, descriptive event counts are not a substitute for an analysis that reports an estimate and its uncertainty. The registry record lists no analyses and does not report confidence intervals, p-values, or a statistical model for the primary endpoint. It also does not report results for the listed pharmacokinetic and pharmacodynamic outcomes. Recognizing what is recorded, what is not analyzed, and what cannot be inferred is essential for a statistically careful reading of a completed trial record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record provides group-level adverse-event counts but not participant-level data, treatment sequences, or period-level results. In a randomized crossover study, those details are important for understanding repeated observations and for assessing how a valid comparison might account for within-participant dependence. The record does not report the statistical model used for any comparison.
The primary endpoint and the posted non-serious-event summaries do not use identical rules. The primary endpoint requires investigator-assessed possible relatedness for non-serious events, while the other non-serious-event counts are reported regardless of relatedness. The registry record does not provide group-level attribution counts, so the primary endpoint cannot be reconstructed from those summaries alone.
The study’s safety timeframe is baseline up to Day 7 post-dose, and the study concerned single doses in healthy participants. The record does not provide evidence about longer-term exposure or other populations. It does not report confidence intervals, formal hypothesis tests, the sample-size justification, missing-data methods, or multiplicity procedures. Results for the listed pharmacokinetic and pharmacodynamic outcomes are also not reported in the registry record. These omissions limit both comparative interpretation and the range of questions the posted results can address.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Single Dose Study of LY3023703 in Healthy Participants — NCT01632579.
- Registry record last updated 2018-08-06; status last verified 2018-07.
- Results first posted 2018-08-06.
- 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
NCT01632579 is a completed phase I randomized, double-blind crossover study of single-dose LY3023703 in healthy participants. Enrollment was 30. The study included placebo and open-label celecoxib as comparators and assessed safety and tolerability, with pharmacokinetic and pharmacodynamic outcomes also listed.
The primary endpoint counted participants with one or more investigator-assessed possibly drug-related adverse events or any serious adverse event from baseline up to Day 7 post-dose. The posted summaries report zero serious adverse events in each listed group and group-specific counts of other non-serious adverse events regardless of possible relatedness. The registry record reports no analyses, formal comparisons, or results for the listed pharmacokinetic and pharmacodynamic outcomes. Group-specific counts should be interpreted in light of the crossover design and should not be summed as distinct participants.