## Protocol Section
### Identification Module
**NCT ID:** NCT06419660

**Brief Title:** A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood

**Official Title:** The Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose BI 3000202 in Healthy Male Subjects (an Open-label, Randomized, Two-way Cross-over Study)

#### Organization Study ID Info
**ID:** 1509-0007
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2023-509209-54-00
**Type:** REGISTRY
**Domain:** WHO International Clinical Trials Registry Platform (ICTRP)
**ID:** U1111-1298-9134
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2024-07-02

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### 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 of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 3000202 in plasma.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** T=test R=reference

**Intervention Names:**

- Drug: BI 300202

- Drug: esomeprazole

**Label:** Esomeprazole + BI 300202 (T) then BI 300202 (R) treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: BI 300202

- Drug: esomeprazole

**Label:** BI 300202 (R) then esomeprazole + BI 300202 (T) treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BI 300202 (R) then esomeprazole + BI 300202 (T) treatment

- Esomeprazole + BI 300202 (T) then BI 300202 (R) treatment

**Description:** BI 300202

**Name:** BI 300202

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- BI 300202 (R) then esomeprazole + BI 300202 (T) treatment

- Esomeprazole + BI 300202 (T) then BI 300202 (R) treatment

**Description:** esomeprazole

**Name:** esomeprazole

**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 (AUC0-tz)

**Time Frame:** Up to 4 days

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

**Time Frame:** Up to 4 days

#### Secondary Outcomes

**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

### 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 55 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 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

**Healthy Volunteers:** True

**Maximum Age:** 55 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

#### Locations

**Location 1:**

**City:** Biberach

**Contacts:**

***Contact 1:***

- **Email:** deutschland@bitrialsupport.com

- **Name:** Boehringer Ingelheim

- **Phone:** 08007234742

- **Role:** CONTACT

**Country:** Germany

**Facility:** Humanpharmakologisches Zentrum Biberach

**Status:** RECRUITING

**Zip:** 88397

### 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

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000897

- Term: Anti-Ulcer Agents

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000054328

- Term: Proton Pump Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M30204

- Name: Esomeprazole

- Relevance: HIGH

- As Found: University

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27630

- Name: Proton Pump Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000064098

- Term: Esomeprazole

### Misc Info Module

- Version Holder: 2024-05-31
