A Study to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body of Healthy Japanese Men

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo matching BI 1815368; Drug: BI 1815368

Study type: Interventional

Funder types: Industry

Identifiers

NCT06494774

1485-0005

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 25 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
• Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese

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 40 to 90 mmHg, or pulse rate outside the range of 40 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 Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 4 patient groups, including a placebo group

SRD part: low dose

Experimental group

Description:

Single-rising dose (SRD)

Treatment:

Drug: BI 1815368

SRD part: medium dose followed by MD part

Experimental group

Description:

Single-rising dose (SRD) Multiple dose (MD)

Treatment:

Drug: BI 1815368

SRD part: high dose

Experimental group

Treatment:

Drug: BI 1815368

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 1815368