Influence of a Standardised High Fat Breakfast on the Bioavailability of BI 14332 CL in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BI 14332 CLOther: high fat breakfast
- Registration Number
- NCT02212938
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥21 and Age ≤65 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BI 14332 CL fed high fat breakfast - BI 14332 CL fasted BI 14332 CL - BI 14332 CL fed BI 14332 CL -
- Primary Outcome Measures
Name Time Method AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 192 hours after drug administration Cmax (maximum measured concentration of the analyte in plasma) up to 192 hours after drug administration
- Secondary Outcome Measures
Name Time Method MRTpo (mean residence time of the analyte in the body after oral administration) up to 192 hours after drug administration CL/F (apparent clearance of the analyte in plasma after extravascular administration) up to 192 hours after drug administration AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) up to 192 hours after drug administration Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) up to 23 days after last drug administration AUCt1-t2 (partial area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) up to 192 hours after drug administration Number of patients with adverse events up to 23 days after last drug administration tmax (time from dosing to the maximum concentration of the analyte in plasma) up to 192 hours after drug administration Assessment of tolerability by investigator on a 4-point scale up to 23 days after last drug administration λz (terminal rate constant in plasma) up to 192 hours after drug administration t1/2 (terminal half-life of the analyte in plasma) up to 192 hours after drug administration Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) up to 192 hours after drug administration Number of patients with clinically significant findings in laboratory tests up to 23 days after last drug administration Number of patients with clinically significant findings in ECG up to 23 days after last drug administration