Status:
COMPLETED
Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability
Eligibility Criteria
Inclusion
- Inclusion criteria:
- healthy male according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- Exclusion criteria:
- Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
- Serum creatinine laboratory value outside the normal range
- estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula \< 90 ml/ min
- Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
- Any evidence of a concomitant disease judged as clinically relevant by the investigator Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
- Serum creatinine laboratory value outside the normal range
- estimated glomerular filtration rate (eGFR) according to CKD-EPI-Creatinine Formula \< 90 ml/ min
- Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02225626
Start Date
September 1 2014
End Date
December 1 2014
Last Update
May 12 2015
Active Locations (1)
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1
1333.44.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany