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

NCT ID: NCT02183311

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30

Brief Summary

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)

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 1356 BS - single rising dose

Group Type: EXPERIMENTAL

BI 1356 BS - single rising dose

Intervention Type: DRUG

BI 1356 BS - multiple rising dose

Group Type: EXPERIMENTAL

BI 1356 BS - multiple rising dose

Intervention Type: DRUG

Placebo

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BI 1356 BS - single rising dose

Intervention Type: DRUG

BI 1356 BS - multiple rising dose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1218.11

Identifier Type: -

Identifier Source: org_study_id