A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
3 other identifiers
interventional
100
1 country
1
Brief Summary
Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses. Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.
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 Apr 2025
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedStudy Start
First participant enrolled
April 7, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 7, 2026
May 22, 2026
May 1, 2026
1.5 years
March 27, 2025
May 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Up to Day 54
Secondary Outcomes (2)
Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss )
Up to Day 42
Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Up to Day 42
Study Arms (7)
Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam)
EXPERIMENTALDose group 2 (receiving BI 3031185 or Placebo, plus midazolam)
EXPERIMENTALDose group 3 (receiving BI 3031185 or Placebo, plus midazolam)
EXPERIMENTALDose group 4 (receiving BI 3031185 or Placebo, plus midazolam)
EXPERIMENTALDose group 5 (receiving BI 3031185 or Placebo, plus midazolam)
EXPERIMENTALDose group 6 (receiving BI 3031185 or Placebo, plus midazolam)
EXPERIMENTALPart B (receiving BI 3031185 or placebo)
EXPERIMENTALInterventions
BI 3031185
Midazolam
Placebo matching BI 3031185
Eligibility Criteria
You may qualify if:
- Part A: 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 Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive)
- Part A: Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential):
- Permanently sterilised (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- Postmenopausal, defined as no menses for at least 1 year without an alternative medical cause. In questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L at screening is confirmatory
You may not qualify if:
- Any finding in the medical examination (including BP, Pulse rate (PR) or 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 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité Research Organisation GmbH
Berlin, 10117, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors may be unblinded upon request, except for Electrocardiogram (ECG) laboratory staff, who shall remain blinded throughout the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 8, 2025
Study Start
April 7, 2025
Primary Completion (Estimated)
October 7, 2026
Study Completion (Estimated)
October 7, 2026
Last Updated
May 22, 2026
Record last verified: 2026-05
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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing