MedDataX Logo

A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood

NCT ID: NCT05380947

Last Updated: 2025-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2022-09-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food

NCT05155306

Healthy
COMPLETED PHASE1

Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects

NCT02170805

Healthy
COMPLETED PHASE1

A Study in Healthy People to Compare Two Different Tablets of BI 685509 and to Test How Food and Esomeprazole Influence the Amount of BI 685509 in the Blood

NCT06193811

Healthy
COMPLETED PHASE1

Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608

NCT01703858

Healthy
COMPLETED PHASE1

Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

NCT02170636

Healthy
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

4-way crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment sequence 1: R - T1 - T2 - T3

Treatments:

R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole

Group Type EXPERIMENTAL

BI 1810631 - trial formulation 1 (TF1)

Intervention Type DRUG

BI 1810631 - trial formulation 1 (TF1)

BI 1810631 - new formulation (NF)

Intervention Type DRUG

BI 1810631 - new formulation (NF)

Rabeprazole sodium

Intervention Type DRUG

Rabeprazole sodium

Treatment sequence 2: T1 - T3 - R - T2

Group Type EXPERIMENTAL

BI 1810631 - trial formulation 1 (TF1)

Intervention Type DRUG

BI 1810631 - trial formulation 1 (TF1)

BI 1810631 - new formulation (NF)

Intervention Type DRUG

BI 1810631 - new formulation (NF)

Rabeprazole sodium

Intervention Type DRUG

Rabeprazole sodium

Treatment sequence 3: T2 - R - T3 - T1

Group Type EXPERIMENTAL

BI 1810631 - trial formulation 1 (TF1)

Intervention Type DRUG

BI 1810631 - trial formulation 1 (TF1)

BI 1810631 - new formulation (NF)

Intervention Type DRUG

BI 1810631 - new formulation (NF)

Rabeprazole sodium

Intervention Type DRUG

Rabeprazole sodium

Treatment sequence 4: T3 - T2 - T1 - R

Group Type EXPERIMENTAL

BI 1810631 - trial formulation 1 (TF1)

Intervention Type DRUG

BI 1810631 - trial formulation 1 (TF1)

BI 1810631 - new formulation (NF)

Intervention Type DRUG

BI 1810631 - new formulation (NF)

Rabeprazole sodium

Intervention Type DRUG

Rabeprazole sodium

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BI 1810631 - trial formulation 1 (TF1)

BI 1810631 - trial formulation 1 (TF1)

Intervention Type DRUG

BI 1810631 - new formulation (NF)

BI 1810631 - new formulation (NF)

Intervention Type DRUG

Rabeprazole sodium

Rabeprazole sodium

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zongertinib, Hernexeos® Zongertinib, Hernexeos® Pariet®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria

* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (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 90 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
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* 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
* History of relevant orthostatic hypotension, fainting spells, or blackouts
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mystudywindow.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-000268-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1479-0003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of BIIB091 Formulations in Healthy Participants
NCT04564612 COMPLETED PHASE1
Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid
NCT06916143 RECRUITING PHASE1
Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects
NCT02170623 COMPLETED PHASE1
Bioavailability of BIBR 953 ZW in Healthy Subjects
NCT02170766 COMPLETED PHASE1
A Study in Healthy People to Test How 2 Different Doses of BI 1291583 Are Taken up in the Body When Given in 3 Different Formulations
NCT06631417 COMPLETED PHASE1
A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food
NCT05337592 COMPLETED PHASE1
Bioavailability of BIBR 963 ZW After 50 mg of BIBR 1048 MS With and Without of Pantoprazole in Healthy Subjects
NCT02170896 COMPLETED PHASE1
Relative Bioavailability of BI 1467335 Tablet and Oral Solution, and Food Effect on Tablet in Healthy Male Subjects
NCT02999191 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 COMPLETED PHASE1
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
NCT02170792 COMPLETED PHASE1
A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood
NCT07250048 RECRUITING PHASE1
A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
NCT05152485 COMPLETED PHASE1
Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions
NCT01897597 COMPLETED PHASE1
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
NCT03837964 COMPLETED PHASE1
Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects
NCT03302078 COMPLETED PHASE1
Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects
NCT01983566 TERMINATED PHASE1
BIBR 953 ZW in Healthy Elderly Subjects
NCT02173730 COMPLETED PHASE1
This Study in Healthy Men Tests How Different Doses of BI 894416 Are Taken up in the Body and How Well BI 894416 is Tolerated
NCT03315936 COMPLETED PHASE1
Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects
NCT02438696 COMPLETED PHASE1
A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food
NCT05520827 COMPLETED PHASE1
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
NCT04445090 TERMINATED PHASE1
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood
NCT06255340 COMPLETED PHASE1
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
NCT01286571 COMPLETED PHASE1
Bioavailability of 3 Different Formulations of BI 207127 in Healthy Male Volunteers
NCT01535638 COMPLETED PHASE1
A Study in Healthy People to Compare 2 Different Formulations of BI 1015550 Taken With or Without Food
NCT05428436 COMPLETED PHASE1