A Study in Healthy People to Test How Itraconazole Influe... | NCT07211425

Studies
A Study in Healthy People to Test How Itraconazole Influences the Amount of BI 3031185 in the Blood

NCT07211425

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Feb 4, 2026Actual

Enrollment

14Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BI 3031185
Itraconazole

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
2025-520654-10-00	Registry Identifier	CTIS
U1111-1316-5119	Registry Identifier	WHO International Clinical Trials Registry Platform (ICTRP)

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2025Actual

Primary Completion Date

Jan 21, 2026Actual

Completion Date

Jan 21, 2026Actual

First Submitted Date

Oct 2, 2025

First Submission Date that Met QC Criteria

Oct 2, 2025

First Posted Date

Oct 8, 2025Actual

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

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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

Description Module

Brief Summary

The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics of a single dose of BI 3031185 following oral administration.

Detailed Description

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 1584862 (R), then BI 1584862 + itraconazole (T)	Experimental	R=Reference treatment (Period 1) T=Test treatment (Period 2)	Drug: BI 3031185 Drug: Itraconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI 3031185	Drug	BI 3031185	BI 1584862 (R), then BI 1584862 + itraconazole (T)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		Up to Day 13
Maximum measured concentration of BI 3031185 in plasma (Cmax)		Up to Day 13

Secondary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)		Up to Day 13

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)), and 12-lead electrocardiogram (ECG)
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg / m^2 (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 BP, Pulse rate (PR) 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (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

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Humanpharmakologisches Zentrum Biberach		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
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds