A Study in Healthy Men to Test How Well Different Doses of BI 3802876 Are Tolerated

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo matching BI 3802876; Drug: BI 3802876

Study type: Interventional

Funder types: Industry

Identifiers

NCT06081530

1517-0001

2023-504538-23-00 (Registry Identifier)

Details and patient eligibility

About

The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.

Enrollment: 59 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of ≥18 to ≤55 years at screening
3. Body mass index (BMI) of ≥ 19.0 to ≤ 28.0 kg/m2 at screening. A minimum body weight of 65 kg at screening
4. Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion criteria

1. Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Three repeated measurements of systolic BP outside the range of 80 to 130 mm Hg, diastolic BP outside the range of 50 to 80 millimetre of mercury (mmHg), or pulse outside the range of 45 to 90 beats per minute.
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

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 9 patient groups, including a placebo group

Part A: BI 3802876 dose group 1

Experimental group

Treatment:

Drug: BI 3802876

Part A: BI 3802876 dose group 2

Experimental group

Treatment:

Drug: BI 3802876

Part A: BI 3802876 dose group 3

Experimental group

Treatment:

Drug: BI 3802876

Part A: BI 3802876 dose group 4

Experimental group

Treatment:

Drug: BI 3802876

Part A: BI 3802876 dose group 5

Experimental group

Treatment:

Drug: BI 3802876

Part A: BI 3802876 dose group 6

Experimental group

Treatment:

Drug: BI 3802876

Part A: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3802876

Part B: BI 3802876

Experimental group

Treatment:

Drug: BI 3802876

Part B: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 3802876