## Protocol Section
### Identification Module
**NCT ID:** NCT06429137

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

**Official Title:** A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects

#### Organization Study ID Info
**ID:** 1519-0001
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2023-510318-25-00
**Type:** REGISTRY
**Domain:** WHO International Clinical Trials Registry Platform (ICTRP)
**ID:** U1111-1304-0523
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-26

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boehringer Ingelheim

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 5

**Type:** EXPERIMENTAL

#### Arm Group 6

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 6

**Type:** EXPERIMENTAL

#### Arm Group 7

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 7

**Type:** EXPERIMENTAL

#### Arm Group 8

**Intervention Names:**

- Drug: BI 3731579

**Label:** BI 3731579 dose group 8

**Type:** EXPERIMENTAL

#### Arm Group 9

**Intervention Names:**

- Drug: Matching placebo to BI 3731579

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BI 3731579 dose group 1

- BI 3731579 dose group 2

- BI 3731579 dose group 3

- BI 3731579 dose group 4

- BI 3731579 dose group 5

- BI 3731579 dose group 6

- BI 3731579 dose group 7

- BI 3731579 dose group 8

**Description:** BI 3731579

**Name:** BI 3731579

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Matching placebo to BI 3731579

**Name:** Matching placebo to BI 3731579

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

**Time Frame:** up to 14 days

#### Secondary Outcomes

**Measure:** Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

**Time Frame:** up to 4 days

**Measure:** Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

**Time Frame:** up to 4 days

**Measure:** Maximum measured concentration of the analyte in plasma (Cmax)

**Time Frame:** up to 4 days

### Eligibility Module

**Eligibility 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 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

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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clintriage.rdg@boehringer-ingelheim.com

**Name:** Boehringer Ingelheim

**Phone:** 1-800-243-0127

**Role:** CONTACT

### IPD Sharing Statement Module

**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

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.mystudywindow.com

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
