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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

NCT ID: NCT06255340

Last Updated: 2024-11-13

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2024-08-28

Brief Summary

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This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The food effect (FE) part of the trial is designed as a randomised, two-sequence, open-label, two period, two-way cross-over trial.

The single rising dose (SRD) part is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

FE part of the trial is designed as open-label. SRD part is designed as blinded to subjects.

Study Groups

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SRD Part: BI 3031185 dose group 1

Single rising dose (SRD)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 2

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 3

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 4

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 5

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 6

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 7

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: BI 3031185 dose group 8

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

SRD Part: Placebo matching BI 3031185

Group Type PLACEBO_COMPARATOR

Placebo matching BI 3031185

Intervention Type DRUG

Placebo

FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions

Food effect (FE)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Interventions

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BI 3031185

BI 3031185

Intervention Type DRUG

Placebo matching BI 3031185

Placebo

Intervention Type DRUG

Eligibility Criteria

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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 without any clinically significant abnormalities
* 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 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 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. 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)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Site Status

Countries

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Germany

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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1516-0001

Identifier Type: -

Identifier Source: org_study_id

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