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Trial record 10 of 187 for:    BI10773

Bioavailability and Pharmacokinetics of BI 10773 Tablet in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02172209
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Food on the Bioavailability and Pharmacokinetics of BI 10773 Tablet, Administered as a Single Dose of 50 mg With and Without Food to Healthy Male Volunteers in an Open-label, Randomised Intraindividual Crossover Comparison Design
Study Start Date : January 2008
Actual Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 10773 tablet administered with food
50 mg BI 10773 after a standardised high fat breakfast
Drug: BI 10773
Active Comparator: BI 10773 tablet administered to fasted subjects
50 mg BI 10773 p.o. after an overnight fast of at least 10 hours
Drug: BI 10773



Primary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 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 ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: 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 Outcome Measures :
  1. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: 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 ]
  2. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: 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 ]
  3. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: 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 ]
  4. 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) [ Time Frame: 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 ]
  5. λz (terminal rate constant in plasma) [ Time Frame: 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 ]
  6. MRTpo (mean residence time of the analyte in the body after p.o. administration) [ Time Frame: 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 ]
  7. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: 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 ]
  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: 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 ]
  9. Glucose excretion in urine [ Time Frame: pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose ]
  10. Creatinine excretion in urine [ Time Frame: pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose ]
  11. Abnormal findings in physical examination [ Time Frame: Baseline and within 14 days after last trial procedure ]
  12. Changes from baseline in vital signs (blood pressure, pulse rate) [ Time Frame: Baseline and within 14 days after last trial procedure ]
  13. Changes from baseline in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline and within 14 days after last trial procedure ]
  14. Changes from baseline in routine laboratory tests [ Time Frame: Baseline and within 14 days after last trial procedure ]
  15. Incidence of adverse events [ Time Frame: Up to 15 days ]
  16. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Within 14 days after last trial procedure ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172209     History of Changes
Other Study ID Numbers: 1245.3
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs