CClinicalTrials.gg
Sign In
CompletedNCT06429137Updated Aug 10, 2026Results posted

A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated

A Phase 1 interventional study of BI 3731579 and Placebo 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 2026-08-10.

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

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 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 45 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 45 years (inclusive)
  3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
  4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to 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 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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 Further exclusion criteria apply
05

Study design

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

Study arms

  • Experimental
    Dose group (DG) 1, 6 mg BI 3731579

    DG 1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 2, 21 mg BI 3731579

    DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 3, 60 mg BI 3731579

    DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 4, 120 mg BI 3731579

    DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 5, 210 mg BI 3731579

    DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 6, 360 mg BI 3731579

    DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 7, 480 mg BI 3731579

    DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Experimental
    DG 8, 600 mg BI 3731579

    DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.

    Drug: BI 3731579

  • Placebo comparator
    Placebo

    This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).

    Drug: Placebo

Interventions

  • DrugBI 3731579

    Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).

  • DrugPlacebo

    Participants received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).

06

What researchers measure

Primary outcomes

  1. Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator

    The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.

    Time frame: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.

Secondary outcomes

  1. AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)

    AUC0-tz (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point) is reported.

    Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

  2. AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

    AUC0-∞ (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity) is reported.

    Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

  3. Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)

    Cmax (maximum measured concentration of BI 3731579 in plasma) is reported.

    Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

07

Results

Posted Aug 10, 2026

Participant flow

This was a partially randomised, single-blind, placebo-controlled trial to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 3731579 administered as tablets to healthy male subjects.

Participant flow — Overall Study
MilestonePlaceboDose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60mg BI 3731579DG 4, 120mg BI 3731579DG 5, 210mg BI 3731579DG 6, 360mg BI 3731579DG 7, 480mg BI 3731579DG 8, 600mg BI 3731579
Started1566666666
Completed1566666666
Not completed000000000

Outcome measures

PrimaryOccurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator

The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.

Time frame:
From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.
Reported as:
Count of participants · Participants
Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator
ParticipantsPlaceboDose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579
Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator000000204
SecondaryAUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)

AUC0-tz (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point) is reported.

Time frame:
Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
Reported as:
Geometric mean · hours·nanomoles/Liter (h·nmol/L)
AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
hours·nanomoles/Liter (h·nmol/L)Dose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579
AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)595 ± 15.43050 ± 30.98360 ± 42.621000 ± 14.135700 ± 27.479900 ± 27.0126000 ± 18.4123000 ± 20.1
SecondaryAUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)

AUC0-∞ (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity) is reported.

Time frame:
Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
Reported as:
Geometric mean · hours·nanomoles/Liter (h·nmol/L)
AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
hours·nanomoles/Liter (h·nmol/L)Dose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579
AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)688 ± 20.93220 ± 31.48570 ± 41.521300 ± 13.336200 ± 27.880900 ± 27.0127000 ± 18.5124000 ± 20.2
SecondaryCmax (Maximum Measured Concentration of BI 3731579 in Plasma)

Cmax (maximum measured concentration of BI 3731579 in plasma) is reported.

Time frame:
Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
Reported as:
Geometric mean · nanomoles/Liter (nmol/L)
Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)
nanomoles/Liter (nmol/L)Dose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579
Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)178 ± 17.2648 ± 40.21730 ± 44.03620 ± 21.05180 ± 40.510800 ± 42.516600 ± 12.415100 ± 17.8

Adverse events

Collected over All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/15 (0%)0/15 (0%)3/15 (20%)
Dose Group (DG) 1, 6mg BI 37315790/6 (0%)0/6 (0%)0/6 (0%)
DG 2, 21 mg BI 37315790/6 (0%)0/6 (0%)1/6 (16.7%)
DG 3, 60 mg BI 37315790/6 (0%)0/6 (0%)0/6 (0%)
DG 4, 120 mg BI 37315790/6 (0%)0/6 (0%)2/6 (33.3%)
DG 5, 210mg BI 37315790/6 (0%)0/6 (0%)2/6 (33.3%)
DG 6, 360mg BI 37315790/6 (0%)0/6 (0%)4/6 (66.7%)
DG 7, 480mg BI 37315790/6 (0%)0/6 (0%)3/6 (50%)
DG 8, 600mg BI 37315790/6 (0%)0/6 (0%)4/6 (66.7%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPlaceboDose Group (DG) 1, 6mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210mg BI 3731579DG 6, 360mg BI 3731579DG 7, 480mg BI 3731579DG 8, 600mg BI 3731579
Urine odour abnormalRenal and urinary disorders0/150/60/60/60/60/60/60/63/6
HeadacheNervous system disorders1/150/60/60/60/60/62/62/61/6
Skin odour abnormalSkin and subcutaneous tissue disorders0/150/60/60/60/60/60/60/62/6
Abdominal discomfortGastrointestinal disorders0/150/60/60/61/60/60/60/60/6
Breath odourGastrointestinal disorders0/150/60/60/60/60/60/60/61/6
Puncture site painGeneral disorders0/150/60/60/60/60/60/61/60/6
PyrexiaGeneral disorders0/150/60/60/60/60/60/61/60/6
Vessel puncture site swellingGeneral disorders0/150/60/60/61/60/60/60/60/6
Pain in extremityMusculoskeletal and connective tissue disorders0/150/61/60/60/60/60/60/60/6
DizzinessNervous system disorders0/150/60/60/60/60/60/60/61/6

Baseline characteristics

Treated set: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug.

Age, Continuous
Age, Continuous(Years)PlaceboDose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579Total
Mean33.5 ± 7.034.2 ± 7.924.7 ± 5.534.3 ± 10.627.8 ± 4.335.8 ± 8.134.5 ± 5.929.2 ± 6.131.7 ± 8.732.0 ± 7.6
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboDose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579Total
Female0000000000
Male156666666663
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboDose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579Total
Hispanic or Latino0010000001
Not Hispanic or Latino156566666662
Unknown or Not Reported0000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboDose Group (DG) 1, 6 mg BI 3731579DG 2, 21 mg BI 3731579DG 3, 60 mg BI 3731579DG 4, 120 mg BI 3731579DG 5, 210 mg BI 3731579DG 6, 360 mg BI 3731579DG 7, 480 mg BI 3731579DG 8, 600 mg BI 3731579Total
American Indian or Alaska Native0000000000
Asian0000010001
Native Hawaiian or Other Pacific Islander0000000000
Black or African American0000000000
White146665566660
More than one race1000100002
Unknown or Not Reported0000000000
08

Study locations

1 site
  • Humanpharmakologisches Zentrum Biberach
    Biberach, 88397, Germany
09

References and documents

Related links

Study documents

  • Study protocol · Feb 10, 2025
  • Statistical analysis plan · Jun 24, 2025

Documents are hosted by the registry — open the source record to download them.

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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06429137
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 24, 2024
Start date
Jul 8, 2024
Primary completion
May 19, 2025
Completion
May 27, 2025
Results posted
Aug 10, 2026
Last update
Aug 10, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Boehringer Ingelheim

Start the discussion