Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers
Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356
 BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg,
 and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)
Inclusion Criteria:

 -  Subjects will be healthy male volunteers who meet the criteria below: Persons without
 clinically remarkable findings or clinically evident complications based on their
 concurrent illness, past medical history, physical examination, vital signs (blood
 pressure (BP), pulse rate (PR), and body temperature), 12-lead Electrocardiogram
 (ECG), and laboratory test results

 -  Persons who are 20 or older and 35 or younger

 -  Persons with a BMI 17.6 kg/m2 or more and 29.9 kg/m2 or less

 -  Persons who are willing to participate in this trial before study initiation and who
 give their written consent in accordance with GCP (Good Clinical Practice, MHW
 Ordinance No. 28 dated March 27, 1997)

 Exclusion Criteria:

 -  Persons who deviate from the norm and who show clinical findings (BP, PR, and ECG) on
 consultation

 -  Persons with any clinically relevant complications

 -  Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
 immune, or hormonal disorders

 -  Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or
 neurological disorders

 -  Persons with a history of significant orthostatic hypotension, syncopal attacks, or
 blackouts

 -  Persons with chronic infection or severe acute infection

 -  Persons with a history of severe allergy/hypersensitivity including allergies to drugs
 and inactive ingredients

 -  Persons who will have received a drug with a long half-life (more than 24 hours)
 within the month before treatment in this trial, within a period 10 times longer than
 the half-life of each drug, or during the study

 -  Persons who will have received a drug that may theoretically affect the study results
 based on the information obtained at the time of preparation of the protocol within
 the 10 days before treatment or during the study

 -  Persons who will have participated in another trial of an investigational drug within
 the 4 months before treatment or during the study

 -  Smokers (who smoke more than 10 cigarettes or 3 cigars or 3 pipes per day)

 -  Persons who cannot abstain from smoking throughout the study

 -  Persons who undoubtedly abuse alcohol

 -  Persons who abuse drugs

 -  Persons who donate blood of 100 mL or more within the 4 weeks before treatment

 -  Persons who perform rigorous exercise (within the week before treatment or during the
 study)

 -  Persons with any laboratory test result outside the reference range and for whom the
 result is considered a clinically relevant change

 -  Persons who cannot obey the dieting rules of the trial site

 -  Persons with any ECG value outside the reference range and who are of clinical
 importance. Examples include, but are not limited to, QRS interval>120 ms