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

NCT06429137 | Completed Phase 1 Results

• 3 other identifiers: 1519-00012023-510318-25-00U1111-1304-0523
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.

Conditions

Healthy

Outcome Measures

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.

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

Secondary Outcomes (3)

• 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)

  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.

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

  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.

• Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)

  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.

Study Arms (9)

Dose group (DG) 1, 6 mg BI 3731579

EXPERIMENTAL

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

DG 2, 21 mg BI 3731579

EXPERIMENTAL

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

DG 3, 60 mg BI 3731579

EXPERIMENTAL

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

DG 4, 120 mg BI 3731579

EXPERIMENTAL

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

DG 5, 210 mg BI 3731579

EXPERIMENTAL

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

DG 6, 360 mg BI 3731579

EXPERIMENTAL

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

DG 7, 480 mg BI 3731579

EXPERIMENTAL

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

DG 8, 600 mg BI 3731579

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Placebo DRUG

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).

Placebo

BI 3731579 DRUG

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).

DG 2, 21 mg BI 3731579; DG 3, 60 mg BI 3731579; DG 4, 120 mg BI 3731579; DG 5, 210 mg BI 3731579; DG 6, 360 mg BI 3731579; DG 7, 480 mg BI 3731579; DG 8, 600 mg BI 3731579; Dose group (DG) 1, 6 mg BI 3731579

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 45 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 of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

You may not qualify if:

• 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 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)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 24, 2024
• Study Start: July 8, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 27, 2025
• Last Updated: August 10, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)