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

July 4, 2014 updated by: Boehringer Ingelheim

Pharmacokinetics of Single and Multiple Oral Doses of 5 mg BI 1356 in Healthy Chinese Volunteers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BI 1356 BS
Drug: BI 1356 BS
single dose
Drug: BI 1356 BS
multiple doses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state)
Time Frame: up to day 19
up to day 19
AUCτ (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to day 19
up to day 19

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: up to 28 days
up to 28 days
Cmax (Maximum measured concentration of the analyte in plasma) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
tmax (Time from dosing to maximum measured concentration) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
Time Frame: up to day 7
up to day 7
AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable analyte plasma concentration after single dose administration)
Time Frame: up to day 7
up to day 7
AUC0-24 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after single dose administration)
Time Frame: up to 24 h after single dose administration
up to 24 h after single dose administration
AUC0-72 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours after single dose administration)
Time Frame: up to 72 h after single dose administration
up to 72 h after single dose administration
λz (Terminal rate constant in plasma) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
t1/2 (Terminal half-life of the analyte in plasma) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
MRTpo (Mean residence time of the analyte in the body) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
CL/F (Apparent clearance of the analyte in plasma after extravascular administration) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
Vz/F (Apparent volume of distribution during the terminal phase λz following extravascular administration) at different time points after single and multiple doses
Time Frame: up to day 19
up to day 19
Aet1-t2 (Amount of analyte that is eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses
Time Frame: up to 168 h after first dose and up to 24 h after last dose
up to 168 h after first dose and up to 24 h after last dose
fet1-t2 (Fraction of analyte eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses
Time Frame: up to 168 h after first dose and up to 24 h after last dose
up to 168 h after first dose and up to 24 h after last dose
Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) for multiple doses
Time Frame: up to 144 h after last dose
up to 144 h after last dose
Cavg,ss (Average concentration of the analyte in plasma at steady state)
Time Frame: up to 144 h after last dose
up to 144 h after last dose
AUCτ,ss (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time Frame: up to 144 h after last dose
up to 144 h after last dose
CLRt1-t2,ss (Renal clearance of the analyte at steady state from time point t1 to time point t2)
Time Frame: up to 144 h after last dose
up to 144 h after last dose
Cpre (Predose concentration of the analyte in plasma) at different time points
Time Frame: up to 120 h after first of multiple doses
up to 120 h after first of multiple doses
PTF (Peak-Trough Fluctuation)
Time Frame: up to 120 h after first of multiple doses
up to 120 h after first of multiple doses
RA,Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on Cmax
Time Frame: up to day 19
up to day 19
RA,AUC (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on AUCτ
Time Frame: up to day 19
up to day 19
Number of patients with abnormal findings in physical examination
Time Frame: up to 25 days
up to 25 days
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 25 days
up to 25 days
Number of patients with clinically significant changes in Vital signs (blood pressure [BP], pulse rate [PR])
Time Frame: up to 25 days
up to 25 days
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time Frame: up to 25 days
up to 25 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1218.58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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