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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3031185; Drug: Placebo matching BI 3031185

Study type: Interventional

Funder types: Industry

Identifiers

NCT06255340

1516-0001

Details and patient eligibility

About

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.

Enrollment: 75 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 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
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 11 patient groups, including a placebo group

SRD Part: BI 3031185 dose group 1

Experimental group

Description:

Single rising dose (SRD)

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 2

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 3

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 4

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 5

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 6

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 7

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: BI 3031185 dose group 8

Experimental group

Treatment:

Drug: BI 3031185

SRD Part: Placebo matching BI 3031185

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3031185

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

Experimental group

Description:

Food effect (FE)

Treatment:

Drug: BI 3031185

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

Experimental group

Treatment:

Drug: BI 3031185