Single Rising Oral Doses of BI 10773 in Healthy Male Volunteers

A Phase I, Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 to 100 mg) of BI 10773 in Healthy Male Volunteers

Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 10773 administered to healthy Japanese male subjects with single rising oral doses (1, 5, 10, 25, and 100 mg).

Inclusion Criteria:

• Healthy male volunteers who meet the following criteria:

  • Without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
  • Age ≥20 and Age ≤35 years
  • Body Mass Index (BMI) ≥18.0 and ≤25.0 kg/m2
  • Persons who are willing to participate in this trial and who give their written consent before study initiation in accordance with the Good Clinical Practice (GCP)

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate, body temperature, 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 a 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 before administration of the investigational product or during the trial

• Use of any drugs within 10 days before administration of the investigational product or during the trial

• Participation in another trial with an investigational drug within four months before administration of the investigational product or during the trial

• Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)

• Inability to refrain from smoking on trial days

• Alcohol abuse

• Drug abuse

• Blood donation (100 mL or more) within four weeks before administration of the investigational product or during the trial

• Excessive physical activities within one week before administration of the investigational product or during the trial

• Basically, a patient with a laboratory value outside the reference range of the clinical site will be excluded form the study. However, if the principal investigator does not see any problem for the subject to enter the study based on the result of assessment of physical examination and other clinical examination, the subject will be able to participate in the study. In this regard, however, subjects who meet one of the following criteria will be excluded from the study:

  • FPG (Fasting plasma glucose) ≥110mg/dL
  • eGFR (estimated glomerular filtration rate) <60
  • abnormal value of urinalysis

• Inability to comply with dietary regimen of the study centre

• 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 TdP (torsade de pointes) (e.g., heart failure, hypokalemia, family history of long QT syndrome)Samsung2014

• Renal glucosuria or elevated urinary glucose levels at screening (>15 mg/dl)

• Any abnormal finding in Kidney or patients who have history of renal disease

• Any other clinical conditions that investigator or sub-investigator judges that the subject is ineligible for study participation