Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers

NCT ID: NCT02183532

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31

Brief Summary

Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of 5 mg in Chinese healthy subjects

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 1356 BS

Group Type: EXPERIMENTAL

BI 1356 BS

Intervention Type: DRUG

single dose

BI 1356 BS

Intervention Type: DRUG

multiple doses

Interventions

BI 1356 BS

single dose

Intervention Type: DRUG

BI 1356 BS

multiple doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male and female Chinese healthy 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, pulse rate, and body temperature), 12-lead Electrocardiogram (ECG), and laboratory test results
• Age ≥18 and Age ≤45 years
• Body weight ≥50 kg with BMI ≥19 and BMI ≤24 kg/m2 (Body Mass Index)
• 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

• Persons who deviate from the norm, and who show clinical findings (Blood pressure (BP), Heart rate (HR), and ECG) on consultation
• Persons with any clinically significant 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 or 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 study, 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 (e.g inhibitors or inducers of Pgp or CYP 3A4)
• 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 significant change
• Persons who cannot obey the dieting rules of the study centre
• 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.
• Pre-menopausal women (last menstruation <1 year prior to the date of informed consent) who:

• are nursing or pregnant
• or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1218.58

Identifier Type: -

Identifier Source: org_study_id