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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-01-09

Study results available
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Summary

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).

Conditions

  • Healthy

Interventions

DRUG

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.

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.

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.

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.

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2024-10-03
Completion
2024-12-18
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504862 on ClinicalTrials.gov