## Protocol Section
### Identification Module
**NCT ID:** NCT06415045

**Brief Title:** A Study in Healthy People to Test How BI 1015550 is Taken up in the Body When Given With or Without Food

**Official Title:** The Effect of Food on the Pharmacokinetics of BI 1015550 (Formulation C2) Following Single Oral Dose Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design)

#### Organization Study ID Info
**ID:** 1305-0039
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2023-509889-38-00
**Type:** REGISTRY
**Domain:** WHO International Clinical Trials Registry Platform (ICTRP)
**ID:** U1111-1301-0891
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-07-24

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-24

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-28

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### 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 objective is to investigate the effect of food on the pharmacokinetics of BI 1015550 Formulation C2.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 18

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: BI 1015550

**Label:** BI 1015550 without food, then BI 1015550 with food

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: BI 1015550

**Label:** BI 1015550 with food, then BI 1015550 without food

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BI 1015550 with food, then BI 1015550 without food

- BI 1015550 without food, then BI 1015550 with food

**Description:** BI 1015550

**Name:** BI 1015550

**Other Names:**

- Nerandomilast

**Type:** DRUG

### Outcomes Module

#### Primary 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 (AUC 0-tz )

**Time Frame:** Up to day 7

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

**Time Frame:** Up to day 7

#### Secondary Outcomes

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

**Time Frame:** Up to day 7

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria :

* Healthy male or female 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 50 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 Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Female subject who meets the criteria defined in the protocol for a highly effective contraception from at least 30 days before the first administration of trial medication until 7 days after last administration

Exclusion Criteria :

* 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 betas per minute (bpm) at screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to depression and suicidal behavior
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**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
