Status:
COMPLETED
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The main objectives of the SRD part of this trial are to investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1356225 in healthy male subjects following oral adminis...
Eligibility Criteria
Inclusion
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- 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
Exclusion
- 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 50 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
- Further exclusion criteria apply
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04065295
Start Date
September 9 2019
End Date
December 23 2019
Last Update
December 14 2022
Active Locations (1)
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1
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397