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

NCT06745297 | Recruiting Phase 1

• 3 other identifiers: 1526-00012024-515222-92-00U1111-1307-8288
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  up to 62 days

• Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)

  up to 27 days

• Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)

  up to 27 days

Secondary Outcomes (6)

• Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 27 days

• Part 1a: Cmax of BI 3776528 in plasma

  up to 27 days

• Part 1b: AUC0-∞ of BI 3776528 in plasma

  up to 27 days

• Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 27 days

• Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)

  up to 27 days

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: BI 3776528; Drug: short-acting benzodiazepine

Placebo group

PLACEBO COMPARATOR

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

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

Interventions

BI 3776528 DRUG

BI 3776528

Treatment group

Placebo matching BI 3776528 DRUG

Placebo matching BI 3776528

Placebo group

short-acting benzodiazepine DRUG

short-acting benzodiazepine

Placebo group; Treatment group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory.
• Age of 18 to 50 years (inclusive)
• BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

You may not qualify if:

• 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
• 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)
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

RECRUITING

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 20, 2024
• Study Start: January 23, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)