Clinical trial NCT06745297: A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Official title: A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 142
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: up to 73 days
measure: 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)
timeFrame: up to 27 days
measure: Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
timeFrame: up to 27 days
Secondary outcomes:
measure: 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)
timeFrame: up to 27 days
measure: Part 1a: Cmax of BI 3776528 in plasma
timeFrame: up to 27 days
measure: Part 1b: AUC0-∞ of BI 3776528 in plasma
timeFrame: up to 27 days
measure: 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)
timeFrame: up to 27 days
measure: 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)
timeFrame: up to 27 days
measure: Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
timeFrame: up to 27 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
References: