A Study to Test How Well Multiple Doses of BI 3810477 Are... | NCT06984926

Studies
A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults

NCT06984926

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Mar 19, 2026Actual

Enrollment

47Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BI 3810477
Placebo

Countries

Belgium

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
2024-519327-20-00	Registry Identifier	CTIS
U1111-1314-5841	Registry Identifier	WHO International Clinical Trials Registry Platform (ICTRP)

Status Module

Record Verification Date

Mar 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

Jun 6, 2025Actual

Primary Completion Date

Mar 9, 2026Actual

Completion Date

Mar 9, 2026Actual

First Submitted Date

May 15, 2025

First Submission Date that Met QC Criteria

May 15, 2025

First Posted Date

May 22, 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

Mar 17, 2026

Last Update Posted Date

Mar 19, 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

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
BI 3810477_dose group 1	Experimental	Drug: BI 3810477
BI 3810477_dose group 2	Experimental	Drug: BI 3810477
BI 3810477_dose group 3	Experimental	Drug: BI 3810477
BI 3810477_dose group 4	Experimental	Drug: BI 3810477
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI 3810477	Drug	BI 3810477	BI 3810477_dose group 1 BI 3810477_dose group 2 BI 3810477_dose group 3 BI 3810477_dose group 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of any treatment-emergent adverse events assessed as drug-related by the investigator		Up to Day 117

Secondary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve of BI 3810477 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)		Up to Day 117
Maximum measured concentration of BI 3810477 in plasma at steady state (Cmax,ss)		Up to Day 117

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female participants 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), respiratory rate (RR), temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
Age of 18 to 60 years (inclusive, to be checked at time of signing informed consent).
BMI of 18.5 to 29.9 kg/m2 (inclusive).
Signed and dated written informed consent in accordance with international conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
Further inclusion criteria apply.

Exclusion Criteria:

Any finding in the medical examination (including BP, PR, RR, temperature 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 100 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

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
SGS Life Science Services - Clinical Research		Edegem		2650	Belgium

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