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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3810477; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06631430

1530-0001

U1111-1306-7752 (Registry Identifier)

2024-513419-28-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 11 patient groups, including a placebo group

Part A: BI 3810477 formulation A dose group 1

Experimental group

Description:

single dose group 1

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 2

Experimental group

Description:

single dose group 2

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 3

Experimental group

Description:

single dose group 3

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 4

Experimental group

Description:

single dose group 4

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 5

Experimental group

Description:

single dose group 5

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 6

Experimental group

Description:

single dose group 6

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A: BI 3810477 formulation A dose group 7

Experimental group

Description:

single dose group 7

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part B: BI 3810477 formulation B dose group 1

Experimental group

Description:

single dose group 1

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part B: BI 3810477 formulation B dose group 2

Experimental group

Description:

single dose group 2

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part B: BI 3810477 formulation B dose group 3

Experimental group

Description:

single dose group 3

Treatment:

Drug: BI 3810477

Drug: BI 3810477

Part A and Part B_Placebo

Placebo Comparator group

Description:

single dose of placebo

Treatment:

Drug: Placebo