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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2026-08-25

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This trial will be conducted in 2 parts: Part 1 (single doses) and Part 2 (multiple doses). Part 1 comprises of 2 subparts: Parts 1a and 1b.

Part 1b starts only after the dose has been tested in part 1a and was safe and of acceptable tolerability.

Part 2 of the study will only commence after the successful administration of the planned dose to the last subject in part 1a.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Part 1a of this trial is a randomized, single-blind, and placebo-controlled. Part 1b of the trial is randomized, open-label, and with a two-way crossover design.

Part 2 of the trial is single-blind, randomized, and placebo-controlled.

Study Groups

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Treatment group

Group Type EXPERIMENTAL

BI 3776528

Intervention Type DRUG

BI 3776528

short-acting benzodiazepine

Intervention Type DRUG

short-acting benzodiazepine

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo matching BI 3776528

Intervention Type DRUG

Placebo matching BI 3776528

short-acting benzodiazepine

Intervention Type DRUG

short-acting benzodiazepine

Interventions

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BI 3776528

Intervention Type DRUG

Placebo matching BI 3776528

Intervention Type DRUG

short-acting benzodiazepine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes