Clinical trial NCT06327256: 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
Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 3000202 in Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with drug-related adverse events
timeFrame: Up to day 20
Secondary outcomes:
measure: Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12)
timeFrame: Up to 12 hours
measure: Maximum measured concentration BI 3000202 in plasma (Cmax)
timeFrame: Up to 24 hours
measure: Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state
timeFrame: Up to day 20
measure: Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state
timeFrame: Up to day 20
measure: Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state
timeFrame: Up to day 20
measure: 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
timeFrame: Up to 2 days
measure: Maximum measured concentration of midazolam in plasma (Cmax) after a single dose
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
References: