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

Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3810477 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 3810477; Drug: BI 3810477

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: BI 3810477 formulation A dose group 1; single dose group 1	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part A: BI 3810477 formulation A dose group 2; single dose group 2	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part A: BI 3810477 formulation A dose group 3; single dose group 3	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part A: BI 3810477 formulation A dose group 4; single dose group 4	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part A: BI 3810477 formulation A dose group 5; single dose group 5	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part A: BI 3810477 formulation A dose group 6; single dose group 6	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part A: BI 3810477 formulation A dose group 7; single dose group 7	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part B: BI 3810477 formulation B dose group 1; single dose group 1	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part B: BI 3810477 formulation B dose group 2; single dose group 2	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Experimental: Part B: BI 3810477 formulation B dose group 3; single dose group 3	Drug: BI 3810477; BI 3810477 formulation A; Drug: BI 3810477; BI 3810477 formulation B
Placebo Comparator: Part A and Part B_Placebo; single dose of placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	Up to Day 85

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 85
Maximum measured concentration of the analyte in plasma (Cmax)	Up to Day 85

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Actual): June 12, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1530-0001; 2024-513419-28-00 (Registry Identifier: CTIS); U1111-1306-7752 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan 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.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No