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A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food

NCT06075277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-09-22

Study results available
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Summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.

Conditions

  • Healthy

Interventions

DRUG

zongertinib

Participants received a single oral dose of 240 mg Zongertinib (4 x 60 mg tablets) in two periods: in Period 1 after an overnight fast of at least 10 hours, and in Period 2 following a high fat/high calorie meal.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2024-01-02
Completion
2024-01-02
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 NCT06075277 on ClinicalTrials.gov