Clinical trial NCT02225626: Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects
Official title: Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-26
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
timeFrame: up to 6 days after last drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 6 days after last drug administration
measure: Frequency of subjects with drug-related adverse events
timeFrame: up to 7 days after last drug administration
Secondary outcomes:
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 6 days after last drug administration
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1333.44.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: