A Study in Healthy Men to Test How Bosentan Influences th... | NCT07649941

Studies
A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood

NCT07649941

Sponsor

Boehringer Ingelheim

Status

Recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

16Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

Zongertinib
Bosentan

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1325-4206	Registry Identifier	WHO International Clinical Trials Registry Platform (ICTRP)
2025-523193-16	Registry Identifier	CTIS

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2026Actual

Primary Completion Date

Aug 19, 2026Estimated

Completion Date

Aug 19, 2026Estimated

First Submitted Date

Jun 11, 2026

First Submission Date that Met QC Criteria

Jun 11, 2026

First Posted Date

Jun 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fixed sequence arm	Experimental	First reference treatment: Zongertinib Then test treatment: Bosentan and Zongertinib	Drug: Zongertinib Drug: Bosentan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zongertinib	Drug	Zongertinib	Fixed sequence arm
Bosentan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)		up to 8 days
Maximum measured concentration of the analyte in plasma (Cmax)		up to 8 days

Secondary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to 8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

Healthy male 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 25 to 55 years (inclusive)
Body mass index (BMI) 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 (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria :

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 (PR) 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
Further exclusion criteria apply.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boehringer Ingelheim	Contact	1-800-243-0127		clintriage.rdg@boehringer-ingelheim.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Humanpharmakologisches Zentrum Biberach	Recruiting	Biberach		88397	Germany

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals