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

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2024-06-06

Brief Summary

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This trial aims to investigate safety, tolerability, and pharmacokinetics following multiple rising doses of BI 1815368 in healthy male subjects.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

Matching placebo

Dose Group 1

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Dose Group 2

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Dose Group 3

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Dose Group 4

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Dose Group 5

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Dose Group 6

Group Type EXPERIMENTAL

BI 1815368

Intervention Type DRUG

BI 1815368

Interventions

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BI 1815368

Intervention Type DRUG

Matching placebo

Intervention Type DRUG

Other Intervention Names

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Placebo

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.
* Age of 18 to 55 years (inclusive).
* Body mass index (BMI) of 19 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(s) 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes