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 Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood (NCT06504862), a non-randomized phase 1 study. The primary outcome is Part 1: Area Under the Concentration-time Curve of Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06504862 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Non-Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Healthy male subjects were enrolled in a two-part pharmacokinetic study. The registry record lists enrollment as 32. The primary endpoint analysis population was a subset defined by the pharmacokinetic analysis criteria; the record does not give its final size in the information available for this analysis.
Intervention
In Part 1, the question concerned a single dose of zongertinib given with a single dose of dabigatran-etexilate. In Part 2, the question concerned zongertinib at steady state given with a single dose of rosuvastatin, metformin and furosemide administered as a cocktail.
Comparator
Each part had a reference treatment followed by a treatment that included zongertinib. Part 1 compared dabigatran-etexilate alone with dabigatran-etexilate given with zongertinib. Part 2 compared the drug cocktail alone with the cocktail given with zongertinib. The sequence was fixed rather than randomized.
Primary question
The primary endpoint was dabigatran plasma exposure in Part 1, measured as AUC from zero extrapolated to infinity. The study asked whether dabigatran exposure differed between the reference treatment and the treatment with zongertinib. The registry record does not report a numerical estimate of that comparison.
3. Trial Design
This was a Phase 1, open-label, nonrandomized, two-part, two-period, fixed-sequence crossover trial. The registry record gives enrollment as 32 and status as completed. The recorded start date is 2024-08-20, and the primary completion date is 2024-10-03. The study enrolled healthy men, rather than people being treated for a disease.
Part 1 focused on dabigatran-etexilate. The reference treatment was dabigatran-etexilate, and the treatment condition included zongertinib and dabigatran-etexilate. Part 2 focused on a cocktail of rosuvastatin, metformin and furosemide, first without zongertinib and then with zongertinib. The stated objectives distinguish a single dose of zongertinib in Part 1 from zongertinib at steady state in Part 2.
In a crossover design, participants can contribute observations under more than one treatment condition, allowing within-participant comparisons. This can account for some stable differences between participants. However, a fixed sequence means treatment order is not randomized. Changes over time, period effects or carryover could therefore complicate interpretation if they are not addressed appropriately. Whether and how these factors were addressed is not reported in the registry record.
The record describes the trial as having no masking and lists nonrandomized allocation. It also cautions that the arms are not a like-for-like control comparison. Thus, the contrast should be read in the context of the stated sequence and study parts, not as a randomized parallel-group comparison. The registry record does not describe the full washout schedule or provide complete details of every administration period.
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 included in the trial if any of the entry criteria were violated.
Period 1, reference treatment (R)
| Stage | Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T) | Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T) |
|---|---|---|
| STARTED | 16 | 16 |
| COMPLETED | 16 | 16 |
| NOT COMPLETED | 0 | 0 |
Transition period
| Stage | Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T) | Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T) |
|---|---|---|
| STARTED | 16 | 16 |
| COMPLETED | 15 | 16 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T) | Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T) |
|---|---|---|
| Adverse Event | 1 | 0 |
Period 2, test treatment (T)
| Stage | Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T) | Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T) |
|---|---|---|
| STARTED | 15 | 16 |
| COMPLETED | 15 | 16 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic parameter analysis set (PKS) restricted to part 1: all part 1 participants in the TS who provided 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. Thus, a participant was included in the PKS, even if he contributed only one PK parameter value for one period to the statistical assessment.
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): all participants who were treated with at least one dose of trial drug.
| Characteristic | Unit | Part 1: Dabigatran-etexilate (R), Then Zongertinib and Dabigatran-etexilate (T) | Part 2: Drug Cocktail (R), Then Zongertinib and Drug Cocktail (T) | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 16 | 32 | |
| Age, Continuous | Years | 35.9 (SD 9.4) | 37.8 (SD 11.2) | 36.9 (SD 10.2) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 16 | 16 | 32 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 16 | 16 | 32 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 15 | 15 | 30 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Part 1: Area Under the Concentration-time Curve of Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), measured over Within 3 hours (h) before dabigatran-etexilate administration (R only), within 3 h prior to zongertinib administration (T only), and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48 h after dabigatran-etexilate administration (R and T)..
| Element | Registry entry |
|---|---|
| Result type | Geometric Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | hour*nanogram/milliliter (h*ng/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the dabigatran plasma concentration-time curve from zero extrapolated to infinity, abbreviated AUC0-∞. It is recorded in hour*nanogram/milliliter. The endpoint applies to Part 1 and represents estimated overall plasma exposure over time, including an extrapolated portion beyond the final measured concentration.
As a general pharmacokinetic concept, area under a concentration-time curve uses information across the concentration profile rather than relying on a single concentration measurement. It is used to compare exposure under different treatment conditions. AUC0-∞ extends the observed profile to estimate exposure beyond the last measured point; the precision of that estimate can depend on the observed data and the extrapolation.
The registry record says the endpoint was summarized with a geometric least squares mean and adjusted geometric standard error, calculated after natural-log transformation and then back-transformed. It also describes plasma sampling before administration and at scheduled times afterward, with measurements extending to 48 h after dabigatran-etexilate administration. The numerical endpoint estimates, their uncertainty intervals and the treatment contrast are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical question is whether dabigatran exposure in Part 1 differed between the reference condition and the condition that included zongertinib. The endpoint chosen for that question is AUC0-∞, a summary of plasma exposure over time. The registry record describes how this endpoint was analyzed but does not report the numerical estimates or a numerical treatment contrast. Consequently, the direction, size and precision of the primary comparison cannot be assessed from the registry information.
A geometric least squares mean is a model-adjusted summary on the original measurement scale after analysis on a logarithmic scale. A treatment contrast based on such summaries is ordinarily interpreted in relative rather than arithmetic-difference terms. That general interpretation does not establish the size or direction of an effect in this trial. No numerical contrast or confidence interval is reported in the registry record, so it is not possible to assess how narrowly or broadly the result is estimated.
The design also matters. The trial used a fixed treatment sequence and was not randomized. Within-participant crossover comparisons can reduce the influence of stable differences between people, but fixed order can leave treatment comparisons vulnerable to time or period effects. The registry record does not state whether a period effect, carryover, or another sequence-related issue was examined, nor does it report the details needed to evaluate those possibilities.
Part 2 addressed different medicines and a different zongertinib condition: zongertinib at steady state was considered with a single-dose cocktail of rosuvastatin, metformin and furosemide. The primary endpoint, however, is specifically the Part 1 dabigatran AUC0-∞ endpoint. Results for the other medicines should not be inferred from that primary endpoint. The listed secondary outcomes include AUC0-tz for dabigatran in Part 1 and for each cocktail medicine in Part 2, but numerical results for those outcomes are not reported in the registry record.
Safety counts are descriptive and do not supply the missing pharmacokinetic comparison. The registry record lists no serious adverse events and no deaths in the reported groups, alongside counts of other adverse events. These counts do not establish whether zongertinib altered exposure, and they should not be treated as a substitute for the endpoint analysis.
Overall, the record identifies the research question, design and analysis approach, but it does not provide the primary result needed to judge the observed difference in dabigatran exposure or its precision. Any conclusion about the direction or magnitude of the pharmacokinetic comparison would go beyond what is reported in the registry record.
9. Statistical Methods Explained
The registry record describes a model-based analysis of the primary pharmacokinetic endpoint. The endpoint was log-transformed using the natural logarithm before fitting an analysis of variance model. The model included participant as a random effect and treatment as a fixed effect. The resulting quantities were then back-transformed to the original scale and reported as geometric least squares means and adjusted geometric standard errors.
Why analyze the endpoint on a logarithmic scale?
As a general statistical explanation, pharmacokinetic measurements can be positive and can vary proportionally: a change by a given factor may be more meaningful than a change by a fixed amount. Taking logarithms can make multiplicative differences easier to model with methods built around additive effects. It can also make a skewed distribution more suitable for a model, although the fit still depends on the observed data and the model assumptions.
After analysis on the log scale, back-transformation returns estimates to the original measurement scale. A geometric least squares mean is therefore not the same as an ordinary arithmetic average. It is a model-adjusted geometric summary. The registry record specifies the model terms used but does not report diagnostic checks, the detailed covariance structure, or other implementation details.
What does the participant effect represent?
The participant effect was treated as random, while treatment was treated as fixed. In general, a participant effect can account for repeated observations from the same person and for baseline differences between people. A fixed treatment effect estimates the contrast among the treatment conditions defined in the analysis. In a crossover setting, this structure is relevant because a participant can contribute observations under more than one condition. The record does not provide the fitted model output or enough detail to verify how all repeated measurements and design features were handled.
What do the geometric standard error and a confidence interval tell us?
The registry record names an adjusted geometric standard error as the measure of dispersion accompanying the geometric least squares mean. In general, a standard error describes the estimated sampling variability of a statistic under the fitted analysis. It is not a direct description of the spread of individual participants' measurements. A confidence interval, when reported, gives a range of values compatible with the data and analysis under its stated procedure. A narrow interval indicates greater precision than a wide interval, but neither the numerical standard errors nor confidence intervals for the primary comparison are reported in the registry record.
The standard error should also be distinguished from the standard deviation of individual measurements. A standard deviation describes variation among observations; a standard error describes uncertainty in an estimated quantity. The registry record names the adjusted geometric standard error but does not state the numerical uncertainty for the endpoint estimates in the information. It is therefore not possible to judge the precision of the primary contrast from the described material.
How does the sampling schedule relate to AUC0-∞?
The primary endpoint was based on dabigatran concentrations measured before administration and at scheduled times afterward. The record lists measurements at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 34 and 48 h after administration, with predose sampling described for the reference and treatment conditions. AUC0-∞ combines exposure across the measured profile with an extrapolation beyond the final quantifiable observation. As a general point, extrapolation introduces dependence on the late concentration profile; the registry record does not provide the numerical extrapolated fraction or related diagnostics.
The analysis population is described as a pharmacokinetic parameter analysis set restricted to Part 1. It includes participants in the TS who contributed at least one primary or secondary pharmacokinetic endpoint, excluding endpoints affected by a protocol deviation relevant to pharmacokinetic evaluation or deemed nonevaluable. The record does not expand the abbreviation TS in the description. It also does not report the number included in the primary endpoint analysis.
The design is a fixed-sequence crossover, but the listed model effects name participant and treatment. Whether the analysis included additional terms for period, sequence, or carryover is not reported in the registry record. Such details matter because a fixed order can make time-related changes difficult to separate from treatment differences. Without the full analysis specification and numerical output, the model description supports an account of the stated approach, not an independent assessment of its fit or assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 12 outcome measures and 12 analyses. It includes the Part 1 primary endpoint for dabigatran AUC0-∞ and secondary AUC0-tz outcomes for dabigatran and the three medicines in the Part 2 cocktail. A multiplicity strategy for interpreting results across these outcomes is not reported in the registry record. Without such a strategy, the record does not establish how the possibility of chance findings across multiple outcomes was handled.
The primary endpoint population is described as a pharmacokinetic analysis set restricted to Part 1. The description says participants had to contribute at least one primary or secondary pharmacokinetic endpoint and excludes endpoints affected by a relevant protocol deviation or considered nonevaluable. The meaning of TS in that definition is not reported in the registry record. The final analysis population size and the number of observations excluded are also not reported in the registry record.
The registry record does not describe how missing pharmacokinetic measurements were handled, whether values below quantification limits were treated in a particular way, or how incomplete concentration profiles affected AUC estimation. It does not state whether missingness was assessed or whether sensitivity analyses were conducted. These details can matter because an AUC depends on the concentration profile, including its late measurements and extrapolation.
These omissions limit assessment of how complete the endpoint data were, how exclusions may have affected the analysis, and how results across outcomes were interpreted. They do not establish that any particular data-handling approach was or was not used; those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Part 1: Dabigatran-etexilate (R) | 0 | 16 | 0.0% |
| Part 1: Zongertinib | 0 | 15 | 0.0% |
| Part 1: Zongertinib and Dabigatran-etexilate (T) | 0 | 15 | 0.0% |
| Part 2: Drug Cocktail (R) | 0 | 16 | 0.0% |
| Part 2: Zongertinib | 0 | 16 | 0.0% |
| Part 2: Zongertinib and Drug Cocktail (T) | 0 | 16 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part 1: Dabigatran-etexilate (R) | 0 of 16 |
| Part 1: Zongertinib | 0 of 15 |
| Part 1: Zongertinib and Dabigatran-etexilate (T) | 0 of 15 |
| Part 2: Drug Cocktail (R) | 0 of 16 |
| Part 2: Zongertinib | 0 of 16 |
| Part 2: Zongertinib and Drug Cocktail (T) | 0 of 16 |
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 |
|---|---|
| Part 1: Dabigatran-etexilate (R) | 2 of 16 |
| Part 1: Zongertinib | 0 of 15 |
| Part 1: Zongertinib and Dabigatran-etexilate (T) | 3 of 15 |
| Part 2: Drug Cocktail (R) | 5 of 16 |
| Part 2: Zongertinib | 9 of 16 |
| Part 2: Zongertinib and Drug Cocktail (T) | 5 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: Dabigatran-etexilate (R) | Part 1: Zongertinib | Part 1: Zongertinib and Dabigatran-etexilate (T) | Part 2: Drug Cocktail (R) | Part 2: Zongertinib | Part 2: Zongertinib and Drug Cocktail (T) |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 0 of 16 | 0 of 15 | 0 of 15 | 2 of 16 | 1 of 16 | 3 of 16 |
| Abdominal pain | Gastrointestinal disorders | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 16 | 3 of 16 | 0 of 16 |
| Diarrhoea | Gastrointestinal disorders | 0 of 16 | 0 of 15 | 1 of 15 | 0 of 16 | 2 of 16 | 0 of 16 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 0 of 16 | 0 of 15 | 1 of 15 | 0 of 16 | 1 of 16 | 0 of 16 |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 16 | 2 of 16 | 0 of 16 |
| Haematoma | Vascular disorders | 1 of 16 | 0 of 15 | 1 of 15 | 0 of 16 | 0 of 16 | 0 of 16 |
| Vertigo | Ear and labyrinth disorders | 0 of 16 | 0 of 15 | 0 of 15 | 1 of 16 | 0 of 16 | 0 of 16 |
| Conjunctival haemorrhage | Eye disorders | 0 of 16 | 0 of 15 | 0 of 15 | 1 of 16 | 0 of 16 | 0 of 16 |
| Flatulence | Gastrointestinal disorders | 0 of 16 | 0 of 15 | 0 of 15 | 0 of 16 | 0 of 16 | 1 of 16 |
| Nausea | Gastrointestinal disorders | 0 of 16 | 0 of 15 | 0 of 15 | 1 of 16 | 0 of 16 | 0 of 16 |
The registry record lists serious adverse events as affecting zero participants in each reported group, with zero deaths in each group. The groups are listed separately for the Part 1 reference treatment, zongertinib, and combination treatment, and for the corresponding Part 2 cocktail conditions. The at-risk counts are 16, 15 and 15 for the listed Part 1 groups, and 16 for each listed Part 2 group. These are group-level counts as recorded; they should not be added to infer a total number of distinct participants.
For other adverse events, the affected counts are 2 in the Part 1 dabigatran-etexilate reference group, 0 in the Part 1 zongertinib group, and 3 in the Part 1 combination group. In Part 2, the affected counts are 5 for the cocktail reference group, 9 for zongertinib, and 5 for the combination group. The listed at-risk counts are 16, 16 and 16 for those Part 2 groups. These counts are descriptive; the registry record does not provide a causal assessment or a statistical comparison of adverse-event counts.
Zero serious events in the listed groups is not proof that serious events cannot occur. The record does not provide event-level descriptions for other adverse events in the information. The counts should be read as reported observations, not as a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
This trial asks a focused pharmacokinetic question in healthy men: whether zongertinib changes exposure to dabigatran in Part 1 and to three medicines administered as a cocktail in Part 2. Its crossover structure allows treatment conditions to be compared within the study sequence, while its fixed order and nonrandomized allocation mean it is not a randomized parallel-group comparison.
The primary endpoint is dabigatran AUC0-∞ in Part 1. The registry record describes its scale, sampling schedule and model-based analysis, but does not report the numerical endpoint estimates, treatment contrast or confidence interval. As a result, the record does not establish the direction, magnitude or precision of the primary comparison. It also does not allow a reader to determine whether the observed comparison met any statistical or clinical threshold.
The stated objectives for Part 2 concern rosuvastatin, metformin and furosemide exposure when given with zongertinib at steady state. Those are distinct pharmacokinetic questions and cannot be answered by the Part 1 primary endpoint. Although the record lists secondary outcomes for these medicines, their numerical results are not reported in the registry record.
The safety counts describe the reported groups, including zero serious adverse events and zero deaths in each group. They do not answer the pharmacokinetic question, and the descriptive counts alone do not establish causation or rule out uncommon events. The registry record also does not describe the multiplicity approach, missing-data handling or all analysis details needed to assess the robustness of the comparisons.
Accordingly, the record supports an understanding of what the trial was designed to examine and how the primary endpoint was specified. It does not support a conclusion about the size or direction of the pharmacokinetic effect. The study's scope is limited to the stated medicines, conditions and healthy male subjects; it does not by itself establish results for other populations or settings.
13. Why This Trial Matters Statistically
Drug interaction questions often concern changes in exposure rather than changes in a clinical outcome. This trial is statistically useful as an example of how such questions can be framed around concentration-time data and summarized with an area under the curve. It distinguishes the dabigatran question in Part 1 from the cocktail question in Part 2, including the different stated zongertinib conditions.
The crossover design is important because it can use within-participant information to compare treatment conditions. That feature may reduce the impact of stable differences among participants. At the same time, the fixed sequence and nonrandomized allocation call for careful attention to order and time effects. Statistical interpretation depends not only on the chosen endpoint, but also on whether the analysis reflects the design and whether the results are reported with enough detail to assess precision.
The registry record describes a natural-log analysis with participant treated as a random effect and treatment as a fixed effect, then back-transforms the geometric least squares means. This is a useful distinction for readers: model-adjusted geometric summaries are not ordinary arithmetic averages, and uncertainty should be interpreted on the scale and using the method stated for the analysis.
The case also illustrates the difference between a clearly specified question and a fully interpretable result. The registry record identifies the primary endpoint and the planned statistical summary, yet the numerical primary comparison and its uncertainty are not reported in the information. Without those results, readers cannot evaluate the estimated effect or its precision. Design and methods provide context, but they cannot replace the outcome estimates.
Finally, the record's group-level adverse-event counts should be kept separate from the pharmacokinetic analysis. Safety observations and exposure measurements answer different questions. Maintaining that distinction helps prevent descriptive counts from being treated as evidence about a pharmacokinetic contrast.
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 most consequential limitation for interpreting the primary question is that numerical dabigatran AUC0-∞ estimates and their treatment contrast are not reported in the registry record. Without those values and their uncertainty, the magnitude, direction and precision of the comparison cannot be assessed.
The fixed-sequence, nonrandomized design leaves potential order-related concerns. Whether period effects or carryover were considered, and whether the washout was adequate for the analyses, is not reported in the registry record. The model description names participant and treatment effects but does not report whether other design terms were included.
The registry record describes a Part 1 pharmacokinetic analysis set but does not report its final size. It also does not provide full details about missing samples, nonevaluable profiles, protocol deviations, or the handling of concentrations below quantification limits. These details can affect which concentration profiles contribute to AUC and how representative the analyzed data are.
Multiplicity handling across the 12 listed outcome measures and 12 analyses is not reported in the registry record. Nor are numerical results for the listed secondary pharmacokinetic outcomes available in the information. This limits interpretation of the broader set of questions, including the Part 2 cocktail medicines.
The record describes healthy male subjects, so the trial's stated population is narrow. The registry information does not establish how findings would apply to other populations or clinical settings. The adverse-event counts are also descriptive and do not include a reported statistical comparison or detailed event-level account in the information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood — NCT06504862.
- Registry record last updated 2026-01-09; status last verified 2025-12.
- Results first posted 2026-01-09.
- 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
NCT06504862 is a completed Phase 1, open-label, nonrandomized, fixed-sequence crossover trial in healthy men, with registry enrollment of 32. It had two parts: Part 1 examined dabigatran-etexilate exposure with and without zongertinib; Part 2 examined a rosuvastatin, metformin and furosemide cocktail with and without zongertinib at steady state.
The primary endpoint was Part 1 dabigatran plasma AUC0-∞. The stated analysis used natural-log-transformed endpoints in an analysis of variance model with participant as a random effect and treatment as a fixed effect, followed by back-transformation. The numerical primary result, treatment contrast and uncertainty are not reported in the registry record. The record lists zero serious adverse events and zero deaths in each reported group, alongside group-specific counts for other adverse events.