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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

NCT06494761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-02

Study results available
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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

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.

DRUG

zongertinib

Participants received 120 mg Zongertinib daily as two 60 mg tablets.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2024-10-16
Completion
2024-10-16
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 NCT06494761 on ClinicalTrials.gov