CompletedNCT06327256Updated Nov 13, 2024

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

A Phase 1 interventional study of BI 3000202 and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 40 participants (actual)

Study arms

Experimental
Dose group 1
Group receiving placebo or dose 1 of BI 3000202
Drug: BI 3000202 · Drug: Placebo
Experimental
Dose group 2
Group receiving placebo or dose 2 of BI 3000202
Drug: BI 3000202 · Drug: Placebo
Experimental
Dose group 3
Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
Drug: BI 3000202 · Drug: Placebo · Drug: Midazolam
Experimental
Dose group 4
Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
Drug: BI 3000202 · Drug: Placebo · Drug: Midazolam

Interventions

DrugBI 3000202
BI 3000202
DrugPlacebo
Placebo-matching BI 3000202
DrugMidazolam
Midazolam

What researchers measure

Primary outcomes

Percentage of subjects with drug-related adverse events
Time frame: Up to day 20

Secondary outcomes

Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12)
Time frame: Up to 12 hours
Maximum measured concentration BI 3000202 in plasma (Cmax)
Time frame: Up to 24 hours
Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state
Time frame: Up to day 20
Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state
Time frame: Up to day 20
Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state
Time frame: 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
Time frame: Up to 2 days
Maximum measured concentration of midazolam in plasma (Cmax) after a single dose
Time frame: Up to 2 days

Study locations

1 site

SGS Life Science Services - Clinical Research
Edegem, 2650, Belgium

References and documents

Individual participant data

Plan to share: No — 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06327256
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Mar 25, 2024
Start date: Apr 9, 2024
Primary completion: Sep 27, 2024
Completion: Sep 27, 2024
Last update: Nov 13, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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