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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02172170
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 10773 single rising dose Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (0.5 mg to 800 mg) of BI 10773 as Tablets Administered to Healthy Male Subjects. A Randomised Placebo-controlled (Within-dose Groups) and Double-blind Trial.
Study Start Date : January 2007
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 10773 single rising dose Drug: BI 10773 single rising dose
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 33 days ]
  2. Number of patients with clinically significant changes in vital signs [ Time Frame: up to 12 days ]
  3. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to day 4 ]
  4. Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG) [ Time Frame: up to 12 days ]
  5. Number of patients with abnormal findings in physical examination [ Time Frame: up to 12 days ]
  6. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to 12 days ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: up to 72 hours after drug administration ]
  3. 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 72 hours after drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 72 hours after drug administration ]
  5. 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: up to 72 hours after drug administration ]
  6. λz (terminal rate constant in plasma) [ Time Frame: up to 72 hours after drug administration ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  8. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: up to 72 hours after drug administration ]
  9. CL/F (total clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 72 hours after drug administration ]
  10. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours after drug administration ]
  11. Ae t1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours after drug administration ]
  12. fe t1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 72 hours after drug administration ]
  13. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 72 hours after drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs ((blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

  2. Age ≥ 18 and Age ≤ 50 years
  3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination including ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG)) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. 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
  10. 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
  11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  13. Inability to refrain from smoking on trial days
  14. Alcohol abuse (more than 60 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  17. Excessive physical activities (within one week prior to administration or during the trial)
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. Inability to comply with the dietary regimen of trial site
  20. A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms);
  21. A history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome);

    Exclusion criteria specific for this study:

  22. Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02172170     History of Changes
Other Study ID Numbers: 1245.1
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