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

NCT06631430 | Completed Phase 1

• 3 other identifiers: 1530-00012024-513419-28-00U1111-1306-7752
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  Up to Day 85

Secondary Outcomes (2)

• 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

Study Arms (11)

Part A: BI 3810477 formulation A dose group 1

EXPERIMENTAL

single dose group 1

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 2

EXPERIMENTAL

single dose group 2

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 3

EXPERIMENTAL

single dose group 3

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 4

EXPERIMENTAL

single dose group 4

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 5

EXPERIMENTAL

single dose group 5

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 6

EXPERIMENTAL

single dose group 6

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 7

EXPERIMENTAL

single dose group 7

Drug: BI 3810477

Part B: BI 3810477 formulation B dose group 1

EXPERIMENTAL

single dose group 1

Drug: BI 3810477

Part B: BI 3810477 formulation B dose group 2

EXPERIMENTAL

single dose group 2

Drug: BI 3810477

Part B: BI 3810477 formulation B dose group 3

EXPERIMENTAL

single dose group 3

Drug: BI 3810477

Part A and Part B_Placebo

PLACEBO COMPARATOR

single dose of placebo

Drug: Placebo

Interventions

BI 3810477 DRUG

BI 3810477 formulation A

Part A: BI 3810477 formulation A dose group 1; Part A: BI 3810477 formulation A dose group 2; Part A: BI 3810477 formulation A dose group 3; Part A: BI 3810477 formulation A dose group 4; Part A: BI 3810477 formulation A dose group 5; Part A: BI 3810477 formulation A dose group 6; Part A: BI 3810477 formulation A dose group 7

Placebo DRUG

Placebo

Part A and Part B_Placebo

Eligibility Criteria

• Age: 18 Years - 60 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 60 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 conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
• 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

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 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)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

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: October 7, 2024
• First Posted: October 8, 2024
• Study Start: October 30, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)