A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo matching BI 3776528; Drug: short-acting benzodiazepine; Drug: BI 3776528

Study type: Interventional

Funder types: Industry

Identifiers

NCT06745297

1526-0001

2024-515222-92-00 (EU Trial (CTIS) Number)

U1111-1307-8288 (Other Identifier)

Details and patient eligibility

About

The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.

Enrollment: 142 estimated patients

Sex: Male

Ages: 18 to 50 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 and clinical laboratory.
2. Age of 18 to 50 years (inclusive)
3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion criteria

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 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)
3. Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
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: Sequential Assignment

Masking: Single Blind

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142 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Treatment:

Drug: BI 3776528

Drug: short-acting benzodiazepine

Placebo group

Placebo Comparator group

Description:

Applicable for part 1a and part 2 of the trial.

Treatment:

Drug: short-acting benzodiazepine

Drug: Placebo matching BI 3776528