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
NCT ID: NCT06327256
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2024-04-09
2024-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Dose group 1
Group receiving placebo or dose 1 of BI 3000202
BI 3000202
BI 3000202
Placebo
Placebo-matching BI 3000202
Dose group 2
Group receiving placebo or dose 2 of BI 3000202
BI 3000202
BI 3000202
Placebo
Placebo-matching BI 3000202
Dose group 3
Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
BI 3000202
BI 3000202
Placebo
Placebo-matching BI 3000202
Midazolam
Midazolam
Dose group 4
Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
BI 3000202
BI 3000202
Placebo
Placebo-matching BI 3000202
Midazolam
Midazolam
Interventions
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BI 3000202
BI 3000202
Placebo
Placebo-matching BI 3000202
Midazolam
Midazolam
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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SGS Life Science Services - Clinical Research
Edegem, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2023-509293-29-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1299-6907
Identifier Type: REGISTRY
Identifier Source: secondary_id
1509-0002
Identifier Type: -
Identifier Source: org_study_id
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