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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 1584862

Study type: Interventional

Funder types: Industry

Identifiers

NCT05520827

2022-001019-15 (EudraCT Number)

1484-0001

Details and patient eligibility

About

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 1584862 in healthy male subjects following oral administration of single rising doses.

Food Effect (FE) part:

The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.

Enrollment: 77 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 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, in particular liver enzymes (AST/ALT) above upper limit of normal and creatinine exceeding 1.2 mg/dl as confirmed by repeat measurements.
• 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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77 participants in 4 patient groups, including a placebo group

Single Rising Dose part: BI 1584862

Experimental group

Treatment:

Drug: BI 1584862

Single Rising Dose part: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Food effect part: BI 1584862 fed (treatment test, T)/ BI 1584862 fasted (treatment reference, R)

Experimental group

Treatment:

Drug: BI 1584862

Food effect part: BI 1584862 fasted (treatment reference, R)/ BI 1584862 fed (treatment test, T)

Experimental group

Treatment:

Drug: BI 1584862