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 in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body (NCT06494761), a na phase 1 study. The primary outcome is Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06494761 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
The trial asked whether multiple doses of zongertinib were associated with changes in the pharmacokinetics of three other medicines: repaglinide, midazolam and omeprazole. The primary endpoint concerned repaglinide; secondary endpoints included concentration-time exposure measures for all three medicines.
Population
Healthy male participants. The registry records an enrollment of 16.
Intervention
Multiple oral doses of zongertinib, with the medicines being evaluated in the trial.
Comparator
Reference treatment periods involving repaglinide, midazolam and omeprazole without zongertinib, compared in sequence with test treatment periods involving zongertinib. The detailed treatment description is incomplete in the registry record.
Primary question
How did repaglinide plasma exposure, measured by AUC from time zero extrapolated to infinity, differ between the reference and test treatment conditions?
This is a pharmacokinetic question: it concerns the concentration of a medicine in plasma over time, rather than a clinical outcome such as symptom improvement or disease progression. The trial also assessed midazolam and omeprazole exposure, but those measures were secondary outcomes.
The registry record does not report numerical results for the primary or secondary pharmacokinetic outcomes. As a result, the direction and size of any exposure differences, and the precision of those estimates, cannot be described from the recorded information. The trial’s healthy-participant setting also defines the scope of the question: the registry does not establish how the pharmacokinetic findings apply to people with a medical condition.
3. Trial Design
This was a Phase 1, open-label, single-group trial with a fixed sequence and two treatment periods, as described in its official title. The registry records an enrollment of 16 and a completed status. The listed study dates are 2024-07-30 for the start and 2024-10-16 for primary completion.
Participants were healthy men. The treatment descriptions identify reference treatments involving repaglinide and a combination of midazolam and omeprazole, followed by test treatments involving zongertinib with the evaluated medicines. The available description identifies the reference treatment as Period 1 and indicates test treatments in Period 2, but the registry record’s treatment details are incomplete. The full dosing schedule and the complete sequence of all treatments are not reported in the registry record.
Open-label means treatment assignment was not masked from participants or study staff. A fixed-sequence design means the treatment conditions were given in a specified order rather than assigned as a randomized sequence. The registry lists allocation as not applicable and identifies the study as single group. Consequently, the periods should not be read as randomized parallel groups or as a like-for-like control comparison. Changes between periods can be assessed within the planned sequence, but period order and other time-related influences are not separated by random assignment.
The registry lists zongertinib, midazolam, omeprazole and repaglinide as drug interventions. It describes pharmacokinetic outcomes based on plasma sampling, including the primary repaglinide measure on Day 1 of Period 1, Day 1 of Period 2 and Day 14 of Period 2. The detailed sampling times are specified in the endpoint description, but the results for those measurements 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: All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Period 1 (Reference Period) (3 days)
| Stage | Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test) |
|---|---|
| STARTED | 16 |
| COMPLETED | 16 |
| NOT COMPLETED | 0 |
Washout (3 days)
| Stage | Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test) |
|---|---|
| STARTED | 16 |
| COMPLETED | 16 |
| NOT COMPLETED | 0 |
Period 2: (Test Period) (15 days)
| Stage | Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test) |
|---|---|
| STARTED | 16 |
| COMPLETED | 14 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test) |
|---|---|
| Adverse Event | 1 |
| Physician Decision | 1 |
Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Two subjects were discontinued by the investigator before Zongertinib administration on Day 2, leading to fewer subjects in Test Treatment 3 Arm.
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: Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
| Characteristic | Unit | Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test) |
|---|---|---|
| Participants analysed | 16 | |
| Age, Continuous | Years | 35.6 (SD 12.1) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 16 |
| 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 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 16 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞), measured over Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | Hours × picomoles per liter (h*pmol/L) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the plasma concentration-time curve for repaglinide from time zero extrapolated to infinity, expressed in hours × picomoles per liter (h*pmol/L). The area under a concentration-time curve, or AUC, represents exposure across the measured and estimated concentration profile. It combines information from concentration levels and the time for which concentrations are present.
The endpoint description lists plasma sampling on Day 1 in Period 1, Day 1 in Period 2 and Day 14 in Period 2. Samples were scheduled before dosing and at a series of times after dosing, with the listed schedule extending to 24 hours after dosing. The endpoint is reported as a geometric mean with geometric coefficient of variation as its dispersion measure. These summaries describe a distribution of positive pharmacokinetic measurements on a multiplicative scale; the coefficient of variation conveys variability relative to the geometric mean.
AUC extrapolated to infinity includes exposure beyond the last quantifiable sample, estimated from the observed concentration profile. It is used in pharmacokinetic work to describe overall exposure, while relying on an extrapolation for the portion after the last measured concentration. The registry does not report the endpoint’s numerical values, the estimated treatment contrast, or its uncertainty. It is therefore not possible to say from the registry record how the primary AUC values compared between treatment conditions or how much of the estimate depended on extrapolation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the trial’s question, population, design and endpoint, but it does not include numerical results for the primary or secondary pharmacokinetic outcomes. In particular, no primary endpoint estimate, treatment contrast, confidence interval or p-value is reported in the registry record. The direction, magnitude and precision of any difference in repaglinide exposure therefore cannot be assessed from this record.
The design was a fixed-sequence study rather than a randomized comparison. Its treatment periods are not independent parallel arms, and the registry explicitly identifies the comparison as not a like-for-like control comparison. A within-sequence comparison can be useful for describing pharmacokinetic changes under the tested conditions, but its interpretation depends on the order and timing of treatment. The record does not report enough detail to evaluate possible period effects, carryover, washout adequacy or other sequence-related considerations.
The stated analysis summary is a geometric mean with geometric coefficient of variation for the primary endpoint. General statistical context: pharmacokinetic measurements are often summarized on a multiplicative scale because exposure values can be skewed and proportional changes may be of interest. A geometric mean is not the same as an arithmetic average, and a geometric coefficient of variation describes relative dispersion. No endpoint values are available to interpret either summary in this trial.
The registry lists 9 outcome measures and 18 analyses. Counts alone do not show which analyses were primary, how the analyses were connected, or whether any adjustment for multiple testing was planned. The multiplicity approach is not reported in the registry record. The primary endpoint is identified, but the broader analysis strategy and any prespecified hierarchy among outcomes are not available.
The safety record lists no serious adverse events and no deaths in any of the recorded treatment groups. It also records non-serious adverse-event counts that vary by group. These are descriptive counts, not a controlled estimate of comparative risk: group sizes differ in some entries, treatments occur in sequence, and the record does not provide event types or an analysis accounting for repeated treatment periods. The safety figures should be read in that context.
The registry’s sample-size assumptions describe planning illustrations based on a fraction of an observed effect, with two-sided significance level 0.05, equal allocation and a normal approximation. Such illustrations are not observed power and are not evidence that a particular effect was detected. The numerical planning outputs and the observed effect used for those illustrations are not reported in the registry record. No conclusion about statistical significance or practical importance follows from the design description alone.
9. Statistical Methods Explained
The available record gives limited information about the statistical methods. It identifies the primary endpoint, its summary measure and dispersion measure, the sampling schedule, and general assumptions for planning illustrations. It does not report the numerical pharmacokinetic results or a complete analysis plan. The statistical concepts below explain how such information is generally interpreted; they do not assert that a particular unreported method was used in this trial.
What does the primary endpoint capture?
In general, AUC summarizes concentration over time. Unlike a single concentration at one sampling time, it reflects the profile across multiple measurements. AUC from time zero extrapolated to infinity adds an estimated tail after the last quantifiable observation. That extrapolation relies on the observed profile and an estimate of how concentrations decline. The registry record describes the endpoint and sampling schedule, but it does not give the estimated AUC values or the details used for extrapolation.
The endpoint is expressed in hours × picomoles per liter (h*pmol/L). Units reflect concentration multiplied by time. The primary endpoint is summarized using a geometric mean and geometric coefficient of variation. In general, geometric summaries are useful when values vary proportionally or are right-skewed, and when ratios are a natural way to express contrasts. A geometric coefficient of variation is a relative measure of dispersion, not a confidence interval. Without the reported estimates, neither the central exposure level nor the variability can be interpreted for this trial.
What would a treatment contrast mean?
In general, a pharmacokinetic comparison asks how exposure under one treatment condition relates to exposure under another. A ratio-scale contrast can express proportional change, while a difference-scale contrast expresses an absolute change. The registry record does not state a numerical contrast, its scale, or an interval estimate for the primary endpoint. It is therefore not possible to quantify or characterize the contrast. No new contrast can be calculated from the record’s enrollment count or endpoint description.
A confidence interval, in general, gives a range of values compatible with the data and the stated statistical model at the interval’s confidence level. Its width conveys precision: a narrower interval indicates more precise estimation than a wider interval, all else being equal. A confidence interval is not a guarantee that the true value lies in the interval, and it does not by itself establish clinical importance. No confidence interval for the primary outcome is reported in the registry record.
How should the design affect interpretation?
In general, random allocation helps balance measured and unmeasured influences between treatment groups. This trial is described as a single-group, fixed-sequence study, with allocation listed as not applicable. The treatment conditions therefore occur in an ordered sequence, rather than as randomized concurrent groups. A comparison across periods can be influenced by period effects, changes over time or carryover from earlier treatment. These are general design considerations, not evidence that any such influence occurred. The registry record does not report methods or results that would permit their assessment.
Open-label means masking was not used. For an objective laboratory concentration measure, lack of masking may be less directly relevant to the measurement itself than it would be for a subjective outcome, but it can still affect study conduct or other assessments. This is general context, not a claim about bias in this trial. The registry record does not describe safeguards or blinding of laboratory or analytical staff.
What do the planning assumptions say?
The registry describes planning illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation and a normal approximation. These are planning assumptions, not evidence of the trial’s actual analysis or of an effect detected. The record’s note distinguishes participants per arm for ordinary outcomes from total events for time-to-event outcomes. The primary pharmacokinetic endpoint is not a time-to-event outcome. Numerical sample-size illustrations and the effect estimate underlying them are not reported in the registry record.
In general, a sample-size calculation estimates the amount of information needed to detect a prespecified effect under specified assumptions. If the assumed effect is reduced, the required sample size generally increases, because smaller differences are harder to distinguish from random variation. Such calculations are prospective planning tools. They are not observed power, which is not an appropriate substitute for interpreting the estimate and its uncertainty after results are available. The registry record does not report the trial’s own sample-size justification.
Over-dispersion is a general concern when observed variability is greater than assumed by a statistical model; it can make standard errors too small if the model fails to account for that variability. The registry gives a geometric coefficient of variation as the endpoint’s dispersion summary, but no values are available to evaluate variability, model fit or precision. The record also does not state whether any additional model was used to account for repeated measurements or sequence effects.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 9 outcome measures and 18 analyses. It identifies repaglinide AUC from time zero extrapolated to infinity as the primary outcome, and lists AUC from time zero to the last quantifiable data point for repaglinide, midazolam and omeprazole among secondary outcomes. The registry record does not provide numerical estimates for these outcomes.
Multiplicity arises when several outcomes, time points, treatment contrasts or analyses are examined. In general, conducting many statistical tests can increase the chance of at least one apparently notable result even when no underlying effect exists. Prespecified priorities or statistical adjustments can help readers interpret a family of tests. The registry record does not report whether multiplicity was addressed, whether a hierarchy was used, or which of the 18 analyses correspond to particular hypotheses. The number of outcomes and analyses does not establish that a correction was or was not applied.
Missing-data handling is also not reported in the registry record. The primary endpoint description identifies a pharmacokinetic analysis set that includes treated participants with at least one eligible primary or secondary pharmacokinetic endpoint, subject to exclusions for relevant protocol deviations or pharmacokinetic non-evaluability. The full population definition and the number of participants included in each analysis are not reported in the registry record. The record does not explain how missing samples, incomplete concentration profiles, or endpoints that could not be evaluated were handled.
These omissions limit assessment of analysis selection and the completeness of the available results. They do not establish that data were missing or that analyses were conducted improperly; they mean the registry record does not describe those details.
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 |
|---|---|---|---|
| Repaglinide (Reference Treatment 1) | 0 | 16 | 0.0% |
| Midazolam + Omeprazole (Reference Treatment 2) | 0 | 16 | 0.0% |
| Zongertinib +Repaglinide (Test Treatment 1) | 0 | 16 | 0.0% |
| Zongertinib +Midazolam +Omeprazole (Test Treatment 2) | 0 | 14 | 0.0% |
| Zongertinib | 0 | 14 | 0.0% |
| Zongertinib +Repaglinide (Test Treatment 3) | 0 | 14 | 0.0% |
| Zongertinib + Midazolam + Omeprazole (Test Treatment 4) | 0 | 14 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Repaglinide (Reference Treatment 1) | 0 of 16 |
| Midazolam + Omeprazole (Reference Treatment 2) | 0 of 16 |
| Zongertinib +Repaglinide (Test Treatment 1) | 0 of 16 |
| Zongertinib +Midazolam +Omeprazole (Test Treatment 2) | 0 of 14 |
| Zongertinib | 0 of 14 |
| Zongertinib +Repaglinide (Test Treatment 3) | 0 of 14 |
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 |
|---|---|
| Repaglinide (Reference Treatment 1) | 2 of 16 |
| Midazolam + Omeprazole (Reference Treatment 2) | 2 of 16 |
| Zongertinib +Repaglinide (Test Treatment 1) | 4 of 16 |
| Zongertinib +Midazolam +Omeprazole (Test Treatment 2) | 4 of 14 |
| Zongertinib | 9 of 14 |
| Zongertinib +Repaglinide (Test Treatment 3) | 2 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Repaglinide (Reference Treatment 1) | Midazolam + Omeprazole (Reference Treatment 2) | Zongertinib +Repaglinide (Test Treatment 1) | Zongertinib +Midazolam +Omeprazole (Test Treatment 2) | Zongertinib | Zongertinib +Repaglinide (Test Treatment 3) |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 1 of 16 | 1 of 16 | 2 of 16 | 1 of 14 | 3 of 14 | 0 of 14 |
| Diarrhoea | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 0 of 16 | 1 of 14 | 2 of 14 | 1 of 14 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 2 of 14 | 0 of 14 |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 2 of 14 | 0 of 14 |
| Dry skin | Skin and subcutaneous tissue disorders | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 2 of 14 | 0 of 14 |
| Atrioventricular block second degree | Cardiac disorders | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 14 | 0 of 14 | 0 of 14 |
| Nausea | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 1 of 14 | 0 of 14 |
| Stomatitis | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 1 of 14 | 0 of 14 |
| Malaise | General disorders | 0 of 16 | 0 of 16 | 0 of 16 | 0 of 14 | 1 of 14 | 0 of 14 |
| Rhinitis | Infections and infestations | 0 of 16 | 0 of 16 | 0 of 16 | 1 of 14 | 0 of 14 | 0 of 14 |
The serious-event figures are recorded separately for each listed treatment group. The registry reports 0 serious adverse events in each group and 0 deaths in each group. The numbers at risk are 16 for the three reference and early test group entries, and 14 for the later test group entries. These are group-level registry counts; they should not be combined into a single trial-wide rate because the treatments are given in sequence and the same participants may contribute to more than one treatment entry.
The record also lists counts under other adverse events: 2 for Repaglinide (Reference Treatment 1), 2 for Midazolam + Omeprazole (Reference Treatment 2), 4 for Zongertinib + Repaglinide (Test Treatment 1), 4 for Zongertinib + Midazolam + Omeprazole (Test Treatment 2), 9 for Zongertinib, 2 for Zongertinib + Repaglinide (Test Treatment 3), and 4 for Zongertinib + Midazolam + Omeprazole (Test Treatment 4). The registry does not provide event terms in the available record.
These figures are descriptive. They do not establish that one treatment caused more events than another, particularly given the sequential design, the different numbers at risk in some groups, and the absence of event-level detail or a comparative safety analysis. The serious-event count of zero is not proof that no serious event could occur in a larger or different population.
12. What the Result Does, and Does Not, Mean
This trial addresses a defined pharmacokinetic question in healthy men: whether multiple doses of zongertinib affected exposure to repaglinide, midazolam and omeprazole. The primary outcome focuses on repaglinide AUC from time zero extrapolated to infinity. The study was completed and enrolled 16 participants, according to the registry record.
The record does not report numerical results for the primary outcome or the secondary pharmacokinetic outcomes. It therefore cannot establish the size or direction of an exposure change, its precision, or whether a statistical comparison met any criterion. The design and endpoint descriptions explain what was intended to be measured, not what the measurements showed.
Even if numerical pharmacokinetic estimates were available, their interpretation would be specific to the tested conditions and study population. This was an open-label, fixed-sequence, single-group study, not a randomized parallel-group comparison. General design considerations include the potential influence of period and sequence, which cannot be assessed from the information reported. The registry record also does not provide enough detail to evaluate the complete treatment schedule or analysis procedures.
The safety record lists no serious adverse events and no deaths in the recorded groups, along with counts of other adverse events. These descriptive entries are not a comparative risk estimate and should not be used to infer that a treatment is safe or unsafe. Event descriptions and a comparative analysis are not reported in the registry record.
Accordingly, the record supports a description of the study’s purpose, design and planned pharmacokinetic measures. It does not support a conclusion about whether zongertinib changed exposure to any of the three medicines, how large any change was, or the clinical implications of a change.
13. Why This Trial Matters Statistically
Pharmacokinetic interaction studies examine how exposure to one medicine changes when another medicine is given. A concentration-time endpoint such as AUC is useful because it summarizes exposure across a profile rather than relying on a single measurement. In this trial, the primary focus was repaglinide, with midazolam and omeprazole also included as secondary pharmacokinetic outcomes.
The design makes the comparison structure important. A fixed sequence can be useful for studying pharmacokinetics within participants, but it differs from randomized parallel groups. The conditions occur in an order, so interpretation depends on the treatment sequence and timing as well as the measured concentrations. The registry identifies the trial as single group and non-randomized, making it inappropriate to read its treatment entries as independent randomized arms.
Statistically, the distinction between a point estimate and its precision matters. A reported estimate would describe the magnitude of an exposure contrast, while a confidence interval would show how precisely it was estimated under the analysis model. Neither is reported for the primary outcome in the registry record. This absence prevents the main statistical question from being answered, despite the detailed endpoint and sampling description.
The record also illustrates why outcome counts and analysis counts need context. It lists 9 outcome measures and 18 analyses, but does not describe a multiplicity strategy or give the numerical results. Without those details, readers cannot determine how the individual tests were prioritized or how to interpret a collection of findings. The planning assumptions are also distinct from trial results: sample-size illustrations based on an observed effect are not observed power.
Thus, the record is informative about the intended pharmacokinetic question and the design’s broad structure, while leaving the numerical evidence needed to judge the exposure comparisons unreported.
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 results for the primary or secondary pharmacokinetic outcomes. There are no reported endpoint estimates, treatment contrasts, confidence intervals or p-values with which to assess direction, magnitude or precision.
The study enrolled 16 healthy men, so the registry describes a small, specific study population. The record does not report numerical analysis-set sizes for the pharmacokinetic outcomes. It also does not provide the complete treatment schedule: the arm description is incomplete, limiting assessment of dosing order and timing from the registry entry alone.
The fixed-sequence, single-group, open-label design is not a randomized comparison. As a general matter, ordered periods can be affected by period or sequence effects; the registry record does not report analyses that would allow readers to assess these possibilities. It also does not report enough information to evaluate washout, carryover, or other design details.
The record lists 9 outcome measures and 18 analyses but does not describe the multiplicity approach, missing-data procedures, or a complete statistical analysis plan. The pharmacokinetic analysis-set description is incomplete in the registry record, and the number of participants contributing to each endpoint is not reported. The registry also does not provide detailed adverse-event terms or a comparative safety analysis. These gaps constrain interpretation of both efficacy-related pharmacokinetic comparisons and safety counts; they do not establish that an unreported analysis or procedure was absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body — NCT06494761.
- Registry record last updated 2025-12-02; status last verified 2025-11.
- Results first posted 2025-12-02.
- 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 describes a completed Phase 1, open-label, single-group, fixed-sequence trial in healthy men, with an enrollment of 16. The listed start date is 2024-07-30, and primary completion is listed as 2024-10-16.
The study’s primary pharmacokinetic endpoint was repaglinide plasma AUC from time zero extrapolated to infinity, reported as a geometric mean with geometric coefficient of variation. Secondary outcomes included AUC from time zero to the last quantifiable data point for repaglinide, midazolam and omeprazole.
The record lists no serious adverse events and no deaths in the treatment groups. It does not report numerical results for the pharmacokinetic outcomes, a complete statistical analysis plan, or full details of missing-data and multiplicity handling. The main exposure comparisons therefore cannot be interpreted from the registry record.