Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BI 1356 BS - multiple rising dose

Drug: BI 1356 BS - single rising dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02183311

1218.11

Details and patient eligibility

About

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)

Enrollment

56 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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