NCT06494761

A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body

The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam, Omeprazole and Repaglinide in Healthy Male Subjects (an Open-label, 2-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 assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	zongertinib	Participants received 120 mg Zongertinib daily as two 60 mg tablets.
DRUG	midazolam	Participants received 1 mg Midazolam as 0.5 mL oral solution.
DRUG	omeprazole	Participants received 20 mg Omeprazole.
DRUG	repaglinide	Participants received a 0.5 mg Repaglinide.

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-10-16
• Completion: 2024-10-16
• First posted: 2024-07-10
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study