A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
- Summary
- The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Short title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-02-03
- First posted
- 2024-12-20
- Registry last updated
- 2026-06-11
- Primary completion date
- 2027-02-03
- Start date
- 2025-01-23
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Boehringer Ingelheim
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06745297
- ClinicalTrials.gov ID
- NCT06745297
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- Single masking
- 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.
- Masked roles
- Participants
Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Timeframe: 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)
Timeframe: up to 27 days
Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
Timeframe: up to 27 days
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
Part 1a: Cmax of BI 3776528 in plasma
Timeframe: up to 27 days
Part 1b: AUC0-∞ of BI 3776528 in plasma
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: up to 27 days
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
- Charité Research Organisation GmbHBerlin, GermanyRecruiting
- Related resource (www.clinicalstudies.boehringer-ingelheim.com)
- 2024-515222-92-00
- U1111-1307-8288