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CompletedNCT06255340Updated Nov 13, 2024

A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood

A Phase 1 interventional study of BI 3031185 and Placebo matching BI 3031185 in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

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

Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.

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 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 without any clinically significant abnormalities
  • Age of 18 to 45 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

Exclusion Criteria:

  • Any finding in the medical examination (including BP, 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 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    SRD Part: BI 3031185 dose group 1

    Single rising dose (SRD)

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 2

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 3

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 4

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 5

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 6

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 7

    Drug: BI 3031185

  • Experimental
    SRD Part: BI 3031185 dose group 8

    Drug: BI 3031185

  • Placebo comparator
    SRD Part: Placebo matching BI 3031185

    Drug: Placebo matching BI 3031185

  • Experimental
    FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions

    Food effect (FE)

    Drug: BI 3031185

  • Experimental
    FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions

    Drug: BI 3031185

Interventions

  • DrugBI 3031185

    BI 3031185

  • DrugPlacebo matching BI 3031185

    Placebo

06

What researchers measure

Primary outcomes

  1. SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator

    Time frame: Up to 22 days

  2. FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)

    Time frame: Up to 24 hours

  3. FE part: Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 8 days

Secondary outcomes

  1. SRD part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)

    Time frame: Up to 24 hours

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

    Time frame: Up to 13 days

  3. FE part: 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 8 days

07

Study locations

1 site
  • Humanpharmakologisches Zentrum Biberach
    Biberach, 88397, Germany
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 Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06255340
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Feb 13, 2024
Start date
Mar 11, 2024
Primary completion
Aug 28, 2024
Completion
Aug 28, 2024
Last update
Nov 13, 2024

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 Nov 2024. You cannot join it, but the record below documents what was studied.

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