Healthy
Conditions
Brief summary
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
Interventions
DRUGBI 3776528
BI 3776528
DRUGPlacebo matching BI 3776528
Placebo matching BI 3776528
DRUGshort-acting benzodiazepine
short-acting benzodiazepine
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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) | up to 27 days |
Countries
Germany
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed