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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2024-12-18

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

fixed-sequence crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Participants were administered a 150 milligram (mg) dabigatran-etexilate hard capsule orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). After a wash-out period, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally, and a 150 mg dabigatran-etexilate hard capsule orally on Day 1 of period 2 (Test treatment, T). Both medications were administered with 240 mL of water after an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

Zongertinib

Intervention Type DRUG

A 120 mg dose on Day 1 of period 2 (Part 1) OR daily (Part 2) with 240 mL of water after an overnight fast of at least 10 hours.

Dabigatran-etexilate

Intervention Type DRUG

A 150 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

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

Participants were administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of period 1 (Reference treatment, R). In period 2, from Day -9 to Day 3, participants were administered two 60 mg film-coated tablets of zongertinib (total dose: 120 mg) orally every day. On Day 1, participants were also administered a cocktail consisting of a 10 mg rosuvastatin film-coated tablet, a 10 mg metformin oral solution, and a 1 mg furosemide oral solution (Test treatment, T). Every medication was administered with 240 mL of water after an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

Zongertinib

Intervention Type DRUG

A 120 mg dose on Day 1 of period 2 (Part 1) OR daily (Part 2) with 240 mL of water after an overnight fast of at least 10 hours.

Rosuvastatin

Intervention Type DRUG

A 10 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Metformin hydrochloride

Intervention Type DRUG

A 10 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Furosemide

Intervention Type DRUG

A 1 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Interventions

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Zongertinib

A 120 mg dose on Day 1 of period 2 (Part 1) OR daily (Part 2) with 240 mL of water after an overnight fast of at least 10 hours.

Intervention Type DRUG

Dabigatran-etexilate

A 150 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Intervention Type DRUG

Rosuvastatin

A 10 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Intervention Type DRUG

Metformin hydrochloride

A 10 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Intervention Type DRUG

Furosemide

A 1 mg dose on Day 1 of each period with 240 mL of water after an overnight fast of at least 10 hours.

Intervention Type DRUG

Other Intervention Names

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Hernexeos® Pradaxa® Crestor® MetfoLiquid GeriaSan® Lasix®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes