Healthy
Conditions
Brief summary
Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects
Interventions
DRUGBI 10773
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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, HR), 12-lead ECG, clinical laboratory tests * Age ≥ 18 and Age ≤ 55 years * 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 (Good Clinical Practice) and the local legislation
Exclusion criteria
* Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) and ECG (electrocardiogram)) 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 or 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 the 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 torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) * Elevated urinary glucose levels at screening (\> 15 mg/dl; \> 0.83 mmol/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| Cmax (maximum measured concentration of the analyte in plasma) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| 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) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| λz (terminal rate constant in plasma) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| MRTpo (mean residence time of the analyte in the body after p.o. administration) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| Glucose excretion in urine | pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose |
| tmax (time from dosing to the maximum concentration of the analyte in plasma) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose |
| Abnormal findings in physical examination | Baseline and within 14 days after last trial procedure |
| Changes from baseline in vital signs (blood pressure, pulse rate) | Baseline and within 14 days after last trial procedure |
| Changes from baseline in 12-lead ECG (electrocardiogram) | Baseline and within 14 days after last trial procedure |
| Changes from baseline in routine laboratory tests | Baseline and within 14 days after last trial procedure |
| Incidence of adverse events | Up to 15 days |
| Assessment of tolerability by investigator on a 4-point scale | Within 14 days after last trial procedure |
| Creatinine excretion in urine | pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose |
| t1/2 (terminal half-life of the analyte in plasma) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours after last dose |
Outcome results
None listed