A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood
NCT ID: NCT05738291
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
67 participants
INTERVENTIONAL
2023-05-01
2024-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The Drug-Drug Interaction (DDI) part of this trial is designed as open-label, within-group comparison interaction trial.
TREATMENT
SINGLE
Study Groups
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MRD part: BI 1839100 dose group 1
Multiple rising dose (MRD)
BI 1839100
BI 1839100
MRD part: BI 1839100 dose group 2
Multiple rising dose (MRD)
BI 1839100
BI 1839100
MRD part: BI 1839100 dose group 3
Multiple rising dose (MRD)
BI 1839100
BI 1839100
MRD part: BI 1839100 dose group 4
Multiple rising dose (MRD)
BI 1839100
BI 1839100
MRD part: BI 1839100 dose group 5
Multiple rising dose (MRD)
BI 1839100
BI 1839100
MRD part: Placebo matching BI 1839100
Placebo matching BI 1839100
Placebo matching BI 1839100
DDI part
Drug-Drug Interaction (DDI)
BI 1839100
BI 1839100
midazolam
midazolam
digoxin
digoxin
rosuvastatin
rosuvastatin
Interventions
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BI 1839100
BI 1839100
Placebo matching BI 1839100
Placebo matching BI 1839100
midazolam
midazolam
digoxin
digoxin
rosuvastatin
rosuvastatin
Eligibility Criteria
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Inclusion Criteria
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
* 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
Exclusion Criteria
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
* 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 assessed as clinically relevant by the investigator
* 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 assessed as clinically relevant by the investigator
18 Years
55 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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ICON-Groningen-62040
Groningen, , Netherlands
Countries
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Related Links
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Related Info
Other Identifiers
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2022-003161-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1490-0002
Identifier Type: -
Identifier Source: org_study_id
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