MedDataX Logo

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

NCT ID: NCT05337592

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2022-10-18

Brief Summary

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

Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses.

Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.

Related Clinical Trials

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

A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men

NCT05857878

Healthy
COMPLETED 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

Healthy
COMPLETED PHASE1

A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321

NCT03971695

Healthy
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

Healthy
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

Healthy
RECRUITING 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

SEQUENTIAL

This study has 2 parts: a single rising dose (SRD) part and a bioavailability (BA) part. For the SRD part the intervention study model is sequential, while for the BA part the intervention study model is crossover.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
For the Single Rising Dose (SRD) part the participant is blinded. For the bioavailability (BA) part no masking is applicable.

Study Groups

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

SRD part: BI 1815368

Group Type EXPERIMENTAL

BI 1815368 formulation 1

Intervention Type DRUG

BI 1815368 formulation 1

SRD part: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

BA part: T1-R-T2

R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition

Group Type EXPERIMENTAL

BI 1815368 formulation 1

Intervention Type DRUG

BI 1815368 formulation 1

BI 1815368 formulation 2

Intervention Type DRUG

BI 1815368 formulation 2

BA part: R-T2-T1

Group Type EXPERIMENTAL

BI 1815368 formulation 1

Intervention Type DRUG

BI 1815368 formulation 1

BI 1815368 formulation 2

Intervention Type DRUG

BI 1815368 formulation 2

BA part: T2-T1-R

Group Type EXPERIMENTAL

BI 1815368 formulation 1

Intervention Type DRUG

BI 1815368 formulation 1

BI 1815368 formulation 2

Intervention Type DRUG

BI 1815368 formulation 2

Interventions

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

BI 1815368 formulation 1

BI 1815368 formulation 1

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

BI 1815368 formulation 2

BI 1815368 formulation 2

Intervention Type DRUG

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 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

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 millimetre 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)
* 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

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.

2021-006856-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1485-0001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
NCT04801693 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
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667
NCT02133482 WITHDRAWN PHASE1
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
NCT04065295 COMPLETED PHASE1
This Study Tests How Different Doses of BI 1291583 Are Taken up in the Body and How Well They Are Tolerated
NCT03414008 TERMINATED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
NCT01971502 COMPLETED PHASE1
To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers
NCT03004404 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
NCT01541488 COMPLETED PHASE1
This Study Tests How Healthy Men Tolerate Different Doses of BI1015550. The Study Also Tests How BI 1015550 is Taken up by the Body
NCT03230487 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
A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.
NCT03854552 COMPLETED PHASE1
Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects
NCT01195688 COMPLETED PHASE1
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX
NCT01587391 COMPLETED PHASE1
A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food
NCT04789291 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male Volunteers
NCT02183298 COMPLETED PHASE1
A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
NCT06429137 COMPLETED PHASE1
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood
NCT03210272 COMPLETED PHASE1
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution
NCT01835899 COMPLETED PHASE1
A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men
NCT06631430 COMPLETED PHASE1
A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People
NCT06575400 ACTIVE_NOT_RECRUITING PHASE1
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
NCT03837964 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects
NCT02172170 COMPLETED PHASE1
Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects
NCT02183493 COMPLETED PHASE1
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
NCT05515328 COMPLETED PHASE1
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
NCT01843972 COMPLETED PHASE1