Phase 1
N=16
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
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06494761 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞) — 28100; 31200; 37300 Hours × picomoles per liter (h*pmol/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- zongertinib (Drug); midazolam (Drug); omeprazole (Drug); repaglinide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞) |
28100; 31200; 37300 | — |
| PRIMARY Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞) |
41400; 44200; 43400 | — |
| PRIMARY Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞) |
378; 359; 296 | — |
| PRIMARY Maximum Measured Concentration of Repaglinide in Plasma (Cmax) |
20200; 23600; 29700 | — |
| PRIMARY Maximum Measured Concentration of Midazolam in Plasma (Cmax) |
17700; 19700; 20800 | — |
| PRIMARY Maximum Measured Concentration of Omeprazole in Plasma (Cmax) |
165; 131; 101 | — |
| SECONDARY Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
27700; 30700; 36700 | — |
| SECONDARY Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
39600; 42700; 41700 | — |
| SECONDARY Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
287; 304; 267 | — |
Summary
The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent
Exclusion Criteria
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT06494761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.