A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rosuvastatin; Drug: Dabigatran-etexilate; Drug: Zongertinib; Drug: Furosemide; Drug: Metformin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT06504862

1479-0015

2024-510628-38-00 (Registry Identifier)

U1111-1302-1171 (Registry Identifier)

Details and patient eligibility

About

For Part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. For Part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).

Enrollment: 32 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Part 1: dabigatran-etexilate (Reference, R) then zongertinib and dabigatran-etexilate (Test, T)

Experimental group

Treatment:

Drug: Zongertinib

Drug: Dabigatran-etexilate

Part 2: Drug cocktail (Reference, R) then zongertinib and drug cocktail (Test, T)

Experimental group

Description:

Drug cocktail: Cocktail of rosuvastatin, metformin and furosemide

Treatment:

Drug: Metformin hydrochloride

Drug: Furosemide

Drug: Zongertinib

Drug: Rosuvastatin