A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated
A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects
3 other identifiers
interventional
63
1 country
1
Brief Summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jul 2024
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 24, 2024
CompletedStudy Start
First participant enrolled
July 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2025
CompletedJune 11, 2025
June 1, 2025
11 months
May 21, 2024
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
up to 14 days
Secondary Outcomes (3)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
up to 4 days
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
up to 4 days
Study Arms (9)
BI 3731579 dose group 1
EXPERIMENTALBI 3731579 dose group 2
EXPERIMENTALBI 3731579 dose group 3
EXPERIMENTALBI 3731579 dose group 4
EXPERIMENTALBI 3731579 dose group 5
EXPERIMENTALBI 3731579 dose group 6
EXPERIMENTALBI 3731579 dose group 7
EXPERIMENTALBI 3731579 dose group 8
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
BI 3731579
Eligibility Criteria
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, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
You may not qualify if:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (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 reference range that the investigator considers to be of clinical relevance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanpharmakologisches Zentrum Biberach
Biberach, 88397, Germany
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2024
First Posted
May 24, 2024
Study Start
July 8, 2024
Primary Completion
May 19, 2025
Study Completion
May 27, 2025
Last Updated
June 11, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency