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Recruiting NCT06916702

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BI 3031185, Midazolam, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Interventions

  • Drug BI 3031185
    BI 3031185
  • Drug Midazolam
    Midazolam
  • Drug Placebo
    Placebo matching BI 3031185

Primary outcome measures

  • Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [Time frame: Up to Day 54]
Secondary outcome measures (2)
  • Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss ) [Time frame: Up to Day 42]
  • Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [Time frame: Up to Day 42]

Eligibility criteria

Inclusion criteria

  • 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
  • Further inclusion criteria apply

Exclusion criteria

  • 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
  • Further exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Charité Research Organisation GmbH — Berlin

Identifiers

NCT: NCT06916702 · 1516-0002 · 2024-516921-29-00 · U1111-1311-3555

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗