NCT06504862

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

The Effect of Zongertinib on the Pharmacokinetics of Dabigatran (Part 1) and Rosuvastatin, Metformin and Furosemide Administered as a Cocktail (Part 2) in Healthy Male Subjects (a 2-part, Open-label, 2-period, Fixed-sequence Cross-over Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-10-03
• Completion: 2024-12-18
• First posted: 2024-07-17
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study