NCT02212938CompletedPhase 1
Influence of a Standardised High Fat Breakfast on the Bioavailability of 10 mg BI 14332 CL Taken as Two Tablets of 5 mg q.d. in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 12
- Primary Endpoint
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Study Overview
Brief Summary
To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
BI 14332 CL fasted
Experimental
Intervention: BI 14332 CL (Drug)
BI 14332 CL fed
Experimental
Intervention: BI 14332 CL (Drug)
BI 14332 CL fed
Experimental
Intervention: high fat breakfast (Other)
Outcomes
Primary Outcomes
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 192 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: up to 192 hours after drug administration
Secondary Outcomes
- MRTpo (mean residence time of the analyte in the body after oral administration)(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)
- 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)
- 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)
- CL/F (apparent clearance of the analyte in plasma after extravascular administration)(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)
Investigators
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