MedDataX Logo

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

NCT ID: NCT07250048

Last Updated: 2025-12-09

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-21

Study Completion Date

2026-05-18

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 3009947 in healthy participants following oral administration of single rising doses.

Bioavailability (BA) part:

The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A.

Related Clinical Trials

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

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 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 in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood

NCT05945888

Healthy
COMPLETED PHASE1

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

Healthy
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

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

SRD part: placebo-controlled BA part: three-way crossover trial with 3 treatment periods to compare the relative bioavailability of reference treatment R and test treatments T1 and T2
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

SRD part: participants masked, single blind BA part: no masking, open label

Study Groups

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

SRD part: BI 3009947 Dose group 4

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 5

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 6

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 7

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

SRD part: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching BI 3009947 (Formulation A)

BA part: Treatment sequence R-T1-T2

Reference treatment R and test treatments T1 and T2.

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

BI 3009947 (Formulation B)

Intervention Type DRUG

BI 3009947 (Formulation B)

BA part: Treatment sequence T1-R-T2

Reference treatment R and test treatments T1 and T2.

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

BI 3009947 (Formulation B)

Intervention Type DRUG

BI 3009947 (Formulation B)

BA part: Treatment sequence T2-R-T1

Reference treatment R and test treatments T1 and T2.

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

BI 3009947 (Formulation B)

Intervention Type DRUG

BI 3009947 (Formulation B)

SRD part: BI 3009947 Dose group 1

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 2

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

SRD part: BI 3009947 Dose group 3

Group Type EXPERIMENTAL

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation A)

Interventions

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

BI 3009947 (Formulation A)

BI 3009947 (Formulation A)

Intervention Type DRUG

BI 3009947 (Formulation B)

BI 3009947 (Formulation B)

Intervention Type DRUG

Placebo

Placebo matching BI 3009947 (Formulation A)

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Healthy male trial participant 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-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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
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 RECRUITING

Countries

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

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Boehringer Ingelheim

Role: CONTACT

[email protected]
1-800-243-0127

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Boehringer Ingelheim

Role: primary

[email protected]
08007234742

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.

2025-521095-66-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1318-3257

Identifier Type: REGISTRY

Identifier Source: secondary_id

1533-0001

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 Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food
NCT05337592 COMPLETED PHASE1
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321
NCT03971695 COMPLETED PHASE1
To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers
NCT03004404 COMPLETED PHASE1
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
NCT03100916 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
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 Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
NCT01541488 COMPLETED PHASE1
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
NCT04065295 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
NCT01971502 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
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
NCT03123185 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 Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.
NCT03854552 COMPLETED PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667
NCT02133482 WITHDRAWN PHASE1
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.
NCT04194645 COMPLETED PHASE1
A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men
NCT06631430 COMPLETED PHASE1
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
NCT03892616 COMPLETED PHASE1
A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood
NCT03794323 COMPLETED PHASE1
A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body
NCT07273474 RECRUITING PHASE1
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
NCT03483077 TERMINATED 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
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
NCT03837964 COMPLETED PHASE1
A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men
NCT05857878 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 1323495 in the Blood of Healthy Men
NCT03802331 COMPLETED PHASE1