Status:
COMPLETED
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 474121 in the Blood
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The main objective of this trial is to investigate the effect on the exposure of BI 474121 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compa...
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 50 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 blood pressure, pulse rate or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04716894
Start Date
February 1 2021
End Date
April 1 2021
Last Update
March 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Humanpharmakologisches Zentrum Biberach
Biberach, Germany, 88397