A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

Boehringer Ingelheim

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo matching BI 3804379; Drug: BI 3804379

Study type: Interventional

Funder types: Industry

Identifiers

NCT06575400

1524-0001

2024-513549-36-00 (Registry Identifier)

U1111-1306-8874 (Registry Identifier)

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses and administration of multiple rising doses.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female (of non-child-bearing potential) 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), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 65 years (inclusive)
3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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56 participants in 4 patient groups, including a placebo group

SRD Part: BI 3804379

Experimental group

Description:

SRD= Single rising dose

Treatment:

Drug: BI 3804379

SRD Part: Placebo matching BI 3804379

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3804379

MRD Part: BI 3804379

Experimental group

Description:

MRD=Multiple rising dose.

Treatment:

Drug: BI 3804379

MRD Part: Placebo matching BI 3804379

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3804379