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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching placebo; Drug: BI 1815368

Study type: Interventional

Funder types: Industry

Identifiers

NCT05857878

2023-503815-13-00 (Registry Identifier)

1485-0002

2022-002278-96 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: Male

Ages: 18 to 55 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 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.
• 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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59 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo

Dose Group 1

Experimental group

Treatment:

Drug: BI 1815368

Dose Group 2

Experimental group

Treatment:

Drug: BI 1815368

Dose Group 3

Experimental group

Treatment:

Drug: BI 1815368

Dose Group 4

Experimental group

Treatment:

Drug: BI 1815368

Dose Group 5

Experimental group

Treatment:

Drug: BI 1815368

Dose Group 6

Experimental group

Treatment:

Drug: BI 1815368