A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam
- Registration Number
- NCT06327256
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Healthy male or female 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 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 Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion Criteria
- 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Further exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose group 3 Placebo Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo Dose group 3 Midazolam Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo Dose group 2 Placebo Group receiving placebo or dose 2 of BI 3000202 Dose group 1 BI 3000202 Group receiving placebo or dose 1 of BI 3000202 Dose group 1 Placebo Group receiving placebo or dose 1 of BI 3000202 Dose group 4 Midazolam Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo Dose group 4 BI 3000202 Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo Dose group 4 Placebo Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo Dose group 2 BI 3000202 Group receiving placebo or dose 2 of BI 3000202 Dose group 3 BI 3000202 Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
- Primary Outcome Measures
Name Time Method Percentage of subjects with drug-related adverse events Up to day 20
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state Up to day 20 Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state Up to day 20 Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state Up to day 20 Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose Up to 2 days Maximum measured concentration of midazolam in plasma (Cmax) after a single dose Up to 2 days Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12) Up to 12 hours Maximum measured concentration BI 3000202 in plasma (Cmax) Up to 24 hours
Trial Locations
- Locations (1)
SGS Life Science Services - Clinical Research
🇧🇪Edegem, Belgium