A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food

NCT07789028 | Not Yet Recruiting Phase 1

• 3 other identifiers: 1479-0067U1111-1335-52722026-525696-77
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0-72h (AUC0-72h)

  up to 4 days

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 4 days

Secondary Outcomes (1)

• Time from dosing to maximum measured concentration of the analyte in plasma (tmax)

  up to 4 days

Study Arms (4)

Treatment sequence 1

EXPERIMENTAL

Test product, fasted condition Reference product, fasted condition Test product, fed condition Reference product, fed condition

Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product

Treatment sequence 2

EXPERIMENTAL

Reference product, fasted condition Reference product, fed condition Test product, fasted condition Test product, fed condition

Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product

Treatment sequence 3

EXPERIMENTAL

Test product, fed condition Test product, fasted condition Reference product, fed condition Reference product, fasted condition

Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product

Treatment sequence 4

EXPERIMENTAL

Reference product, fed condition Test product, fed condition Reference product, fasted condition Test product, fasted condition

Drug: Zongertinib, Formulation A, reference product; Drug: Zongertinib Formulation B, test product

Interventions

Zongertinib, Formulation A, reference product DRUG

Zongertinib, Formulation A, reference product

Also known as: BI 1810631

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3; Treatment sequence 4

Zongertinib Formulation B, test product DRUG

Zongertinib Formulation B, test product

Also known as: BI 1810631

Treatment sequence 1; Treatment sequence 2; Treatment sequence 3; Treatment sequence 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body mass index of 18.5 to 29.9 kg/m² (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice and local legislation prior to admission to the trial

You may not qualify if:

• Any finding in the medical examination (including BP, PR rate or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 9, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)