NCT06028464

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood

The Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zongertinib	Participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours.
DRUG	Carbamazepine	Participants received increasing doses of Carbamazepine once daily as extended-release tablets with 240 mL of water for 18 days, starting at 200 mg, then 400 mg, and finally 600 mg. Afterward, they continued taking 600 mg of Carbamazepine once daily for 6 days.

Timeline

• Start date: 2023-09-11
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2023-09-08
• Last updated: 2025-11-05
• Results posted: 2025-11-05

Locations

1 site across 1 country: Germany