A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
NCT ID: NCT04445090
Last Updated: 2021-11-12
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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TERMINATED
PHASE1
68 participants
INTERVENTIONAL
2020-07-21
2021-09-10
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
TREATMENT
SINGLE
Study Groups
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Single Rising Dose part: BI 1569912
BI 1569912
BI 1569912
Single Rising Dose part: Placebo
Placebo
Placebo
Bioavailability and Food effect part: BI 1569912
This part follows the SRD part; open-label, randomised, single-dose, intraindividual, six-sequence, three-way crossover
BI 1569912
BI 1569912
Interventions
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BI 1569912
BI 1569912
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age of 18 to 45 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
* Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
* Sexually abstinent
* Surgically sterilised (including hysterectomy of female partner)
* Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
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 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
* 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)
* History of relevant orthostatic hypotension, fainting spells, or any unexplained blackouts
* Chronic or relevant acute infections
* A positive polymerase chain reaction (PCR) test for SARS-CoV-2/COVID-19 and/ or any clinical symptom suggestive for this disease at screening and on Day -3.
18 Years
45 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Charité - Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Related Links
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Related Info
Other Identifiers
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2019-004836-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1447-0001
Identifier Type: -
Identifier Source: org_study_id