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CompletedNCT06631430Updated Jun 18, 2025

A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men

A Phase 1 interventional study of BI 3810477 and BI 3810477 in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3810477 in healthy male subjects.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male subjects 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
  2. Age of 18 to 60 years (inclusive)
  3. Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
  4. 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
  5. Male subjects who are willing to use condoms to prevent unintended exposure of their partner (both, male and female) from time point of administration of trial medication until completion of the trial

Exclusion criteria

Exclusion criteria

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  2. 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)
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  5. Further exclusion criteria apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Part A: BI 3810477 formulation A dose group 1

    single dose group 1

    Drug: BI 3810477

  • Experimental
    Part A: BI 3810477 formulation A dose group 2

    single dose group 2

    Drug: BI 3810477

  • Experimental
    Part A: BI 3810477 formulation A dose group 3

    single dose group 3

    Drug: BI 3810477

  • Experimental
    Part A: BI 3810477 formulation A dose group 4

    single dose group 4

    Drug: BI 3810477

  • Experimental
    Part A: BI 3810477 formulation A dose group 5

    single dose group 5

    Drug: BI 3810477

  • Experimental
    Part A: BI 3810477 formulation A dose group 6

    single dose group 6

    Drug: BI 3810477

  • Experimental
    Part A: BI 3810477 formulation A dose group 7

    single dose group 7

    Drug: BI 3810477

  • Experimental
    Part B: BI 3810477 formulation B dose group 1

    single dose group 1

    Drug: BI 3810477

  • Experimental
    Part B: BI 3810477 formulation B dose group 2

    single dose group 2

    Drug: BI 3810477

  • Experimental
    Part B: BI 3810477 formulation B dose group 3

    single dose group 3

    Drug: BI 3810477

  • Placebo comparator
    Part A and Part B_Placebo

    single dose of placebo

    Drug: Placebo

Interventions

  • DrugBI 3810477

    BI 3810477 formulation A

  • DrugBI 3810477

    BI 3810477 formulation B

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

    Time frame: Up to Day 85

Secondary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to Day 85

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to Day 85

07

Study locations

1 site
  • SGS Life Science Services - Clinical Research
    Edegem, 2650, Belgium
08

References and documents

Related links

Individual participant data

Plan to share: No — 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.mystudywindow.com/msw/datatransparency

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06631430
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Oct 30, 2024
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Last update
Jun 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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